Senior Medical Director, PVRM
$288.2k - $360.2kSumitomo Pharma
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
Job Overview
The Pharmacovigilance and Risk Management (PVRM) Senior Medical Director will be responsible for the medical safety aspects of clinical trials including review/addressing safety queries related to protocol Informed Consent Form (ICF), Safety Management Plan (SMP), Clinical Study report (CSR), Investigator Brochure (IB) safety section etc., Also, the medical review and assessment of individual case safety reports, including seriousness, expectedness, quality of the narrative, adverse event coding and causality. The Senior Medical Director will also provide medical safety subject matter expertise in the review and approval of documents including but not limited to aggregate safety reports, including PSUR, PBRER, DSUR, PADER, Company core data sheets, local approved labels, RMP/REMS, Regulatory Authorities safety inquiries, IRB/ethics committee safety questions, Health hazard assessments. The incumbent will provide medical safety support for safety signal management throughout product lifecycle including signal detection, signal validation, signal escalation, development of risk mitigation strategies and authoring of signal evaluation reports according to established safety governance policies and keeping senior leadership informed of safety issues. This individual will perform the above duties independently and report to the VP, PVRM and Global Pharmacovigilance Head.
Job Duties and Responsibilities
Lead safety strategy and key messaging in NDA/BLA/MAA submissions
Lead ongoing safety monitoring of assigned investigational and marketed products.
Providing PVRM Medical representation on product specific and/or clinical study team meetings and governance committees.
Prepare and present safety data analysis to project teams and senior management, for assigned products
Evaluate safety data and contribute/author safety sections as a medical safety subject matter expert (SME) on behalf of PVRM for: Study Protocols, Informed Consent Forms (ICF), Safety Management Plans (SMP), Clinical Study Reports (CSR), and Investigator's Brochures (IB)
Contribute to preparation and update of Company Core Data Sheets (CCDS), Locally labels such as, United States Prescribing Information (USPI), European Summary of Product Characteristics (SmPC), Canadian Product Monograph (PM), and Risk Management Plans (RMPs)/Risk Evaluation and Mitigation Strategy (REMS)
Medical review of Aggregate Reports (PADER, PSUR, PBRER, DSUR, IND/NDA Annual Reports)
Handle Health Hazard Evaluations and Ad-Hoc Regulatory safety inquiries.
Perform aggregate safety data review in support of signal and trend detection activities, safety evaluation/analysis/investigation, risk benefit management and other departmental activities as appropriate.
Participate/contribute to other activities such as literature evaluation, investigator site training, continuing education for internal staff, audits, and inspections.
Develop and maintain strong relationship with cross-functional teams such as Clinical Development, pre-clinical Safety, Clinical Operations and Clinical Pharmacology.
Maintain a working knowledge of applicable global regulatory authority regulations.
Support PVRM or cross-functional ad-hoc projects or assignments that require safety input
Ensure compliance with regulations/internal SOPs and fosters a culture of "Patient first" in line with SMPA's values and related behaviors.
Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives, adverse event coding, concomitant medication coding, and causality statements
Key Core Competencies
Thorough knowledge of the pharma industry especially clinical research and global regulatory requirements and experience managing expedited and periodic safety reporting, signal generation, safety evaluation and risk managements strategies.
Thorough knowledge of FDA and ICH safety reporting regulations and guidelines.
Demonstrated strategic and critical thinking, strong communication skills (both oral and written)
Ability to work effectively in teams, strong interpersonal skills, and the ability to lead directly or indirectly with influence.
Strong problem solving, conflict resolution and analytical skills.
Ability to travel both domestically and internationally as required.
Demonstrate coaching skills to develop a team.
High degree of organizational awareness, ability to connect the dots to understand all the interdependency and big picture.
Education and Experience
Medical Degree (MD) with 12 + years of relevant experience in biotech or pharmaceutical industry
Experience in Oncology and Neurology is preferred
Experience with NDA/BLA/MAA submission
Prior people management experience
The base salary range for this role is
$288,200.00 - $360,200.00
Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law.
Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Mental/Physical Requirements:
Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Travel Requirements:
Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.
Drug Screening Requirements
Applicants for sales/field, manufacturing, or other designated roles will be required to submit to a pre-employment drug test.
Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at View email address on click.appcast.io . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website or follow us on LinkedIn.
Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at View email address on click.appcast.io
This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
SMPA may use Artificial Intelligence ("AI") as part of the job application process, including to assist us in evaluating your application. By submitting your information, you acknowledge that the company may use AI tools as part of our evaluation.
At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars.
Our Mission
To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people worldwide
Our Vision
For Longer and Healthier Lives, we unlock the future with cutting edge technology and ideas
$284.32k - $355.4k
...follow us on LinkedIn. We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Medical Director, Clinical Research (Neurology) to join our R&D Organization. This individual will contribute to the design and execution...SeniorWorldwideFlexible hours$121.2k - $169.67k
...within healthcare settings. The compensation ranges from $121,200 to $169,666 annually, reflective of the selected candidate's qualifications and experience. Benefits include medical, dental, vision insurance, 401(k) with matching, and paid time off. #J-18808-Ljbffr...SeniorFull time- Spacelabs Healthcare is seeking a Principal Clinical Excellence Specialist to join their team. This role is responsible for providing clinical consultation to sales teams and prospective customers while maintaining crucial customer relationships across various healthcare...SeniorRemote work
$249.97k - $388.13k
...Otsuka is seeking an experienced and visionary Senior Director, Global Clinical Development (GCD), with experience in immunology, who will... ...teams, and ensuring the highest standards of scientific and medical integrity. The incumbent will be responsible for the design and...SeniorTemporary workLocal areaFlexible hours- ...Senior Healthcare Planner At Corgan we are passionate about great design but the best thing we build is each other. Here, you'll find camaraderie and collaboration as abundantly as curiosity and creativity. Corgan is a welcoming and supportive environment that provides...SeniorFull timeWork at officeMonday to Friday
- Description McMillan Pazdan Smith is an award-winning architecture, interior design, and advisory services firm with eight studios located in the southeast. We pride ourselves on strong client relationships and community partnerships. Our projects represent the work of...SeniorLocal area
- ...A global technology company is seeking a Senior Industry Principal to act as a trusted advisor to key clients, leveraging expertise in supply chain management and business strategy. This remote position requires 10-15 years of relevant experience, with a strong background...SeniorRemote work
$82.5k - $166.1k
...take on a pivotal role in transforming healthcare systems? As a Senior Clinical Consultant, you will play a crucial part in shaping... ...comprehensive benefits package which includes the following: # Medical, dental, and vision insurance, including expert medical opinion...SeniorTemporary workVisa sponsorshipFlexible hours$31.83 - $63.65 per hour
...preceding factors as well as internal peer equity. Oracle US offers a comprehensive benefits package which includes the following: # Medical, dental, and vision insurance, including expert medical opinion # Short term disability and long term disability # Life...SeniorHourly payTemporary workFlexible hours$124k - $280k
...Senior Manager, Data and Analytics Engineering At PwC, our people in data and analytics engineering focus on leveraging advanced... ...discretionary bonus. PwC offers a wide range of benefits, including medical, dental, vision, 401k, holiday pay, vacation, personal and...Senior$165.1k - $313.15k
...innovative clients seeking answers to complex business challenges. Senior Healthcare Consultant Tasks Manage and develop clients among... ...to execution to results presentation A deep understanding of medical coding systems (CPT, ICD, DRG, etc.) Detail oriented, capable of...SeniorFull timeContract workTemporary workWork experience placementRemote workFlexible hours- Job Description Seeking a M3 Maintenance Customer Order (MCO) focused Sr/Principal Consultant for a multi-division distribution project in the flooring/building sector. The ideal candidate will have extensive experience in the Company’s M3 cloud solutions, specifically...Senior
- ...Transaction Advisory Services Healthcare Senior Manager/ Director Job Category: Transaction Adv Services Requisition Number: TRANS001166 Full-Time Locations: Atlanta, GA, USA +3 more locations Description Do you have an entrepreneurial mindset and are you wanting...SeniorFull timeLocal area
$162k - $324k
Healthcare Investment Consultant We are seeking a talented individual to join our Healthcare Investment team at Mercer, a Marsh company. This role can be based in New York, Chicago, Boston, Atlanta, L.A., Seattle, Phoenix, Minneapolis, and St. Louis. This is a hybrid...SeniorMinimum wageWork at officeLocal areaRemote workFlexible hours3 days per week1 day per week$30k
...engaged, and passionate veterinary leader with several years of clinical experience to lead our team of clinicians in the role of Medical Director . The Medical Director will partner in leadership with hospital administration to create a sense of community and interact...Full timeRelocation package- ...Center (EAC) is seeking a visionary physician leader to serve as Medical Director and drive the next phase of growth for one of the Southeast's premier autism service and research centers. This is a senior leadership role for a physician at the Associate Professor or...Remote workWork from home
$223.8k - $313.1k
...Become a part of our caring community The Medical Director uses their medical background, experience, and judgement. You will make determinations whether they should authorize requested services, request level of care, and requested site of service at the Initial or...Bi-weekly payFull timeTemporary workApprenticeshipWork at officeRemote workWork from homeHome office$170 - $175 per hour
...Medical Director Req number: R7707 Employment type: Full time Worksite flexibility: Remote Who we are CAI is a global services firm with over 9,000 associates worldwide and a yearly revenue of $1.3 billion+. We have over 40 years of excellence in...Hourly payFull timeApprenticeshipPrivate practiceWork at officeLocal areaRemote workWorldwide$223.8k - $313.1k
A leading U.S. healthcare company is seeking a Medical Director to perform expert clinical reviews of inpatient medical records and advance high-quality healthcare decision-making. Ideal candidates are experienced physicians with backgrounds in critical care or inpatient...Remote work$223.8k - $313.1k
...Become a part of our caring community The Medical Director relies on fundamentals of CMS Medicare Guidance on following and reviewing Home Health, SNF, DME, dual Medicare/Medicaid requests. The Medical Director reviews and determines whether healthcare services provided...Full timeTemporary workApprenticeshipWork at officeRemote workWork from homeHome officeMonday to Friday- ...inclusive environment where your wellbeing comes first Position Overview We are seeking a compassionate and skilled Veterinarian or Medical Director to join our team at Browns Bridge Animal Hospital, a well‑established practice just northeast of Atlanta. The ideal candidate...Local area
- ...The Medical Director, Utilization Management provides clinical leadership and oversight for RxBenefits' utilization management (UM) programs, ensuring that medical and pharmacy review activities are clinically appropriate, evidence-based, and compliant with applicable...Part timeWork at officeLocal area
$223.8k - $313.1k
...Become a part of our caring community The Medical Director relies on medical background and reviews health claims. The Medical Director work assignments involve moderately complex to complex issues where the analysis of situations or data requires an in-depth evaluation...Bi-weekly payFull timeTemporary workApprenticeshipWork at officeLocal areaRemote workWork from homeHome officeMonday to FridayWeekend work$227.6k
...in accordance with the highest and most current clinical standards. The incumbent reviews escalated cases electronically and using Medical Policy criteria sets to evaluate the medical necessity and appropriateness of the requested treatment of service. Depending on the...For contractorsPrivate practiceWork at officeLocal area- ...feasibility, protocol writing or optimization, medical monitoring and pharmacovigilance. Parexel... ...in learning more about the Medical Director role. *Candidates with a subspecialty in... ...service groups, and assume the role of Senior Technical Lead in selected circumstances....Contract workRemote work
$160k
...Description MEDICAL DIRECTOR - THRIVE DECATUR About You As a leader in our hospital, you'll drive positive change and growth. Your influence will shape our vision, foster an exceptional culture, and maintain high standards of care. Partnering with the practice...Full timeTemporary workLocal areaMonday to Friday$210k - $256.67k
...Infosys Consulting is seeking an experienced and strategic Senior Principal with deep expertise in SAP Business Data Cloud (BDC),... ...compensation range: $210,000-$256,667. Benefits include: ~ Medical/Dental/Vision/Life Insurance ~ Long-term/Short-term Disability...SeniorTemporary work$187.27k - $318.26k
...success of the Enterprise analytic product portfolio. In this senior individual contributor role, you will focus on working backward... ...history of defining product vision and roadmaps at a senior level (Director, Principal, or Head of Product equivalent) is essential. ~...SeniorFull time- The City of Atlanta is hiring for an inspector role responsible for ensuring compliance with fire sprinkler systems regulations. The successful candidate will conduct inspections and provide assistance on NFPA codes and installation. Candidates must have at least 5 years...Senior
$270.8k - $378.8k
...Become a part of our caring community The National Medical Director of Clinical Excellence & Safety is a pivotal leadership position within CenterWell Senior Primary Care. This role is responsible for guiding patient safety initiatives, ensuring clinical quality, and...Full timeTemporary workApprenticeshipWork at officeRemote workWork from homeHome office
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Medical Director, PVRM. Be the first to apply!
- mental health clinical supervisor Atlanta, GA
- medical director remote Atlanta, GA
- clinical data manager remote Atlanta, GA
- healthcare consulting manager Atlanta, GA
- clinical services director Atlanta, GA
- assistant clinical manager Atlanta, GA
- healthcare supervisor Atlanta, GA
- associate director clinical research Atlanta, GA
- psychiatry medical director Atlanta, GA
- remote medical coding supervisor Atlanta, GA


