Medical Affairs/Safety - Manager, PV Scientist
TalentBurst Inc
Job Description
Job Description
PV Scientist, Contractor, Safety Risk Management
6 Months
Remote
Summary of Key Responsibilities
- Works closely with the safety lead physician to analyze potential safety issues, including signal detection, signal evaluation and signal management. Collaborates proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas.
- Contribute to signaling and data mining activities utilizing internal and external sources of data. Performs signaling data review from all sources including but not limited to: Empirica, Clinical and Safety outputs, Literature, and HA requests
- Assists in evaluation and development of Safety Management Plans
- Assists in data analysis compilation and presentation at cross-functional meetings.
- Assists in the evaluation of potential safety issues.
- Contributes to activities related to the functioning of safety committees, including but not limited to, preparing reports, minutes and meeting documents; ensuring completion of action items; and, participating in the discussion of patient safety issues.
- Contributes to the development and management of SOPs, work practices and guidelines, forms and templates, and other communications related to risk management and product safety.
- Assists in RMP and DRMP development and updates.
Qualifications
Education : Degree in a medical or healthcare related discipline (PharmD, RN, MD) is required
Experience : A minimum of five to seven years in the pharmaceutical industry with experience in drug safety/pharmacovigilance. Previous experience in managing drug safety personnel a plus. Specific experience in RNA therapeutic area at a global level is an advantage.
Strong skills and experience in :
Ability to work in a matrix environment in accordance with the company leadership commitments and values.
Excellent planning, organization, written and oral communication skills
Advanced knowledge of Global (including US, EU, LATAM, APAC) Pharmacovigilance regulatory requirements
Understanding Signaling tools (eg. Empirica)
Experience in clinical patient care is a plus
Regulatory Inspection readiness experience is a plus
Supervision: Individual is expected to work independently with support from management and colleagues in SRM. #TB_PH
#ZR
Why TalentBurst?
At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.
Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.
We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.
TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.
\nCompany DescriptionFounded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA
Company Description
Founded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA
Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Medical Affairs/Safety - Manager, PV Scientist in Cambridge, MA vacancy
$68 - $80 per hour
...experiencePosition Summary The PV Aggregate Reports Scientist is part of the Safety Surveillance and... ...and is responsible for managing the processes for all aggregate... ...the authoring of medical and scientific safety information... ...Development, Medical Affairs, Clinical Operations,...MedicalLocal areaWorldwide$172k - $237k
...Associate Director for the Safety Surveillance and Aggregate... ...You’ll Do Serve as the lead PV Scientist for a specific product or group... ...signal detection and management activities, Risk Management... ...MD, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory...MedicalFull timeTemporary workWork at officeLocal area$65 - $77 per hour
job summary: The PV Aggregate Reports Scientist is part of the Safety Surveillance and Aggregate (... ...and is responsible for managing the processes for all aggregate... ...the authoring of medical and scientific safety information... ...Development, Medical Affairs, Clinical Operations,...MedicalHourly payContract workTemporary workWork experience placementLocal areaWorldwideCambridge, MA8 days ago$187k - $281k
The Director, Safety Scientist serves as a key leader within Global Patient... ...for the evaluation and management of safety risks across the portfolio... ...close partnership with GPS Medical Directors and cross-... ...compliance and adherence to PV regulations for the assigned...MedicalFull timeTemporary workLocal area$105.28k - $197.4k
...DescriptionWe are searching for an experienced Clinical Affairs Scientist (CAS) to work within the medical diagnostic field as a key member of the Organization... ...partners, R&D scientists, Clinical Trial Managers/ Clinical Research Associates, Quality Assurance, and...MedicalFull timeLocal areaRemote work- IntelliPro seeks a PV Drug Safety Consultant to join our Hybrid Cambridge team. The role focuses on managing PSUR/DSUR/PADER and local reports across global safety programs... ...collaborate with Safety, Clinical Development, Medical Affairs and Regulatory teams, interpreting data...MedicalLocal area
$70 - $78 per hour
...with a hybrid contract opening for a PV Aggregate Reports Scientist within the Safety Surveillance and Aggregate (SSA)... ...requirements and PV processes. Manage aggregate report schedules, stakeholder... .... Collaborate with PV, Clinical, Medical, Regulatory, Quality, and external...MedicalContract workLocal area$126k - $190k
The Associate Director, Safety Scientist plays a pivotal role within Global... ...leadership and project management to proactively evaluate and... ...close collaboration with GPS Medical Director(s) and cross-functional... ...and reputational impact of PV actionsThe duties of this role...MedicalFull timeTemporary workWork at officeLocal area$220k - $240k
...Facebook.Role Summary:The Director, Drug Safety & Pharmacovigilance Scientist provides strategic and scientific... ...benefit-risk evaluation, and risk management activities across Dyne’s... ..., Clinical Operations, Regulatory Affairs, Medical Affairs, Biostatistics, Data Management...MedicalLocal area$200k - $250k
OverviewThe Director of Drug Safety & Pharmacovigilance... ..., oncology risk management, and complex benefit-risk... ...disease severity, unmet medical need, and evolving clinical... ...‑stage biotech.Manage PV vendors and CROs... ...Development, Regulatory Affairs, Medical Affairs, Biostatistics...Medical$220k - $340k
...the RoleThe Global Safety Officer (GSO) serves as the core medical safety expert and strategic... ...a physician-scientist who can operate... ...Development, Regulatory Affairs, Biostatistics,... ...and Kymera's Safety Management Team.Title (Medical... ...in partnership with PV operationsEnsure safety...Medical$187k - $281k
...The Director, Safety Scientist serves as a key leader within Global Patient... ...for the evaluation and management of safety risks across the portfolio... ...close partnership with GPS Medical Directors and cross-... ...compliance and adherence to PV regulations for the assigned...MedicalTemporary workLocal area$126k - $190k
...plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team... ...You will be responsible for: Managing safety scientist activities across multiple product portfolios...MedicalTemporary workAstraZeneca
Boston, MA3 days ago$133k - $212k
Job TitleMedical Safety Manager, Hospital Patient MonitoringJob DescriptionMedical Safety Manager, HPMThe Medical Safety Manager, Hospital Patient Monitoring is responsible for conducting... ...’s in areas such as Medical/Clinical affairs in Medical Device/Biotech industry or...MedicalFull timeWork at officeImmediate startWork visaRelocation package3 days per week$79.56k - $115.72k
...believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us... ...Brigham. Summary Responsible for overseeing and managing all aspects of environmental, health, and safety programs within an organization including developing...MedicalLocal areaRemote workShift work$120k - $165k
...Business System which makes everything possible.Principal Clinical Scientist. This role is responsible for clinical trial strategies... ...evidence plans.Partner cross‑functionally with R&D, Regulatory, Medical Affairs, Quality, and Commercial teams to align clinical programs...MedicalFull timeImmediate startRemote workWork from homeFlexible hours$116k - $182.27k
...shine? Join us as a Clinical Scientist, Neuroimmunology & Specialty... ...Clinical Scientist will integrate medical, scientific, regulatory, and... ..., biostatistics, regulatory affairs, and medical affairs to align... ..., including clinical trial management systems and electronic data capture...MedicalMinimum wageTemporary workWork at officeLocal areaRemote work$137.5k - $178k
...PV Scientist Replimune's mission is to revolutionize cancer treatment... ...Reports to: Sr Director, Safety Risk Management & PV Sciences Summary of... ...Sciences and support the medical component of... ...Biostatistics, Regulatory Affairs, Contract Research and other...MedicalContract workLocal areaFlexible hoursReplimune
Woburn, MA4 days ago- Hydrogen Group is seeking a Drug Safety Consultant for a 12-month contract based... ...will support the SSA Reports team, manage global aggregate PV reports (PSURs, DSURs, PADERs, local... ..., Regulatory, Clinical Development, Medical Affairs, and external partners to ensure high...MedicalContract workWork at officeLocal area
- ...monitoring and continued assessment of safety profile through systematic signal detection... ...teams (e. g. Safety Risk Management Teams). *Serve as the safety expert providing... ...product, and being knowledgeable about the (medical) context of the respective product class...Medical
$109.2k - $273k
...support for clinical development and drug safety activities. This role will leverage... ...Clinical Development, Safety, Regulatory Affairs, Biostatistics, and Real-World Evidence stakeholders... ...and commercialization of innovative medical treatments to help improve patient...MedicalFull timePart timeImmediate startRemote workWorldwide$203.71k - $305.56k
...data quality, and a seamless safety evaluation process. How will you... ...to anticipate, detect and manage risk.Cross-Functional Delivery... ...Operations, Biostatistics, Regulatory Affairs, Patient Safety, and early... ...with health authorities.Medical Monitoring Support: Support medical...MedicalFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week- ...assignment/freelancer (no medical/paid leave) Duration of... ...Biologist” roles. Clinical Scientist, Clinical Development... ...Scientist, Bioanalytical CRO Management, DMPK (Orexin Programs)... ...Associate Director, Drug Safety and Pharmacovigilance (PV) Scientist Principal AI...MedicalContract workFor contractorsFreelanceRemote workWorldwide
Turing
Boston, MA20 hours ago $120k - $123k
...team on the same page as well as helps managers plan for big content opportunities Collaborate... ...news, promotion, production, community affairs, engineering, and IT Participate in... ...available for this position include medical, dental, vision, 401(k) plan, life...MedicalFull timeLive inLocal areaFlexible hoursWeekend workDay shiftAfternoon shiftParamount Unified School District
Boston, MA2 days ago$260.3k - $409.7k
...opportunity for a physician-scientist to join our group as a- Principal... ...and simulation, regulatory affairs, and global clinical trials... ...stage through Phase 1 studies of safety, tolerability,... ...- Available benefits include medical, dental, vision healthcare and...MedicalFull timeFor contractorsLocal areaWorldwideRelocationVisa sponsorshipFlexible hoursShift workMerck & Co.
Boston, MA9 days ago$255.8k - $402.7k
...Clinical Director (Principal Scientist) has primary... ...Clinical Director may manage the entire cycle of clinical... ...support decisions regarding safety and efficacy as well as... ..., regulatory affairs, statistics, and manufacturing... ...benefits include medical, dental, vision healthcare...MedicalFull timeFor contractorsLocal areaFlexible hours$184k - $200k
...Director, Pharmacovigilance Scientist Location: Remote or,... ...will support the ongoing safety evaluation and... ...Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Medical Writing, Quality, external... ...assessment. • Collaborate with PV vendors and CROs to...MedicalRemote workCandel Therapeutics
Needham Heights, MA1 day ago$190.8k - $300.3k
...in scientific standards, medical data review practices,... ...responsibility for direct management and development of multiple Clinical Scientists and is expected to... ...Operations, Regulatory Affairs, Biostatistics and Data Management, Drug Safety and Pharmacovigilance, Translational...MedicalFull timeFor contractorsLocal areaFlexible hours- ...Medical Laboratory Technician (Clinical Laboratory Scientist) The Medical Laboratory Technician (Clinical Laboratory Scientist... ...of the Department of Veterans Affairs at the VA Boston Healthcare... ...Follow infection control, patient safety, and information security protocols...Medical
Aptive Resources
West Roxbury, MA20 hours ago - ...will do: The Global Safety Program Lead, Senior... ...safety physicians and scientists responsible for the development... ...advantage. Line manages a team of safety... ...FSIRB, and DSMB/DMC, Medical Affairs Review Committees (MARC... ...compliance and adherence to PV regulations of the...MedicalHourly payTemporary workLocal area
Alexion Pharmaceuticals
Boston, MA20 hours ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Medical Affairs/Safety - Manager, PV Scientist. Be the first to apply!
Related searches
- junior clinical data manager Cambridge, MA
- remote medical coding supervisor Cambridge, MA
- health services manager Cambridge, MA
- occupational health manager Cambridge, MA
- lead clinical data manager Cambridge, MA
- healthcare program manager Cambridge, MA
- clinical nutrition manager Cambridge, MA
- clinical research director Cambridge, MA
- associate director clinical operations Cambridge, MA
- director sr. director clinical operations Cambridge, MA