Senior Director, Drug Safety & Pharmacovigilance
Confidential
Senior Director, Drug Safety & Pharmacovigilance
About the Company
A well-funded, clinical-stage biotechnology company focused on autoimmune and inflammatory diseases.
Industry
Biotechnology
Type
Privately Held, VC-backed
About the Role
The Company is seeking a Senior Director of Drug Safety and Pharmacovigilance to lead global safety and pharmacovigilance activities, ensuring compliance with all regulatory requirements and guidance. The successful candidate will be responsible for the oversight of adverse event case processing, aggregate safety reporting, and providing leadership on safety inputs across clinical and regulatory documents. This role involves close collaboration with clinical leads and medical monitors, serving as the primary point of contact for safety and PV-related matters, and leading the development and optimization of safety processes. The Senior Director will also be tasked with overseeing safety/PV vendors, driving continuous improvement of PV systems, and supporting regulatory interactions. Applicants must have an M.D. or foreign equivalent, with a minimum of 5 years of industry experience in pharmacovigilance. The role requires a leader who can ensure high-quality, timely submissions to regulatory agencies and stakeholders, and who is adept at partnering cross-functionally to support integrated program execution. The ideal candidate will have a proven track record in safety personnel management, be adept at supporting performance and development, and be committed to fostering a high-performing team environment. Experience in overseeing safety/PV vendors, and a strong background in safety document development and maintenance, including core data sheets, labeling, and risk management plans, are essential. The position is suited to individuals who are looking to make a significant impact in a high-growth, science-driven environment.
Functions
- Medical Care/Hospital Administration
- Operations
- Dormont Manufacturing Co is seeking a Sr. Medical Director in Drug Safety & Pharmacovigilance to provide safety strategy for drug development projects in Cambridge, Massachusetts. Responsibilities include developing pharmacovigilance strategies, overseeing signal detection...Senior
$131.04k - $196.55k
Senior Manager/Associate Director, Global Safety Scientist, MSRM Agios Pharmaceuticals is searching for a dynamic Global Safety Scientist to join... ...) with a minimum of 4-6 years of relevant drug safety/pharmacovigilance experience; training in pharmacology, epidemiology...SeniorTemporary workRemote workWork from homeWorldwideFlexible hours3 days per week- ...operations based in Boston, Massachusetts and San Francisco, California.Position SummaryReporting to the Head of Pharmacovigilance Operations, the Senior Manager, Drug Safety will play a pivotal role in compliance oversight, end-to-end case management and author drug safety SOPs...SeniorRemote work
Crispr-Therapeutics-1
Boston, MA20 hours ago $140k - $155k
CRISPR Therapeutics in Boston is seeking a Senior Manager, Drug Safety to lead compliance oversight and end-to-end case management. The role... ...The ideal candidate has a Bachelor's degree, 10+ years in pharmacovigilance, and strong regulatory understanding. The position...Senior$140k - $155k
CRISPR Therapeutics is seeking a Senior Manager, Drug Safety in Boston. This role involves compliance oversight, managing ICSR processing, and... ...have a bachelor's degree and significant experience in pharmacovigilance, including knowledge of global regulations and ICSR...Senior$140k - $155k
...manage ICSR processing activities and ensure compliance with drug safety regulations. The candidate should have a Bachelor’s degree... ...10+ years of experience with a strong background in global pharmacovigilance and ICSR processes. The role includes developing drug safety...Senior- TFS HealthScience, a leading mid-size Contract Research Organization in Boston, seeks a Senior Lead Drug Safety to oversee drug safety and pharmacovigilance activities. This role requires strong leadership and hands-on operational delivery. The ideal candidate will have...SeniorContract work
$280k - $420k
...Sr. Medical Director, Drug Safety & Pharmacovigilance Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating...SeniorContract workLocal areaFlexible hours$228k - $280k
...Pioneering in Cambridge, MA is seeking a Senior Director, Head of Toxicology to lead the... ...This role involves defining nonclinical safety strategies, overseeing regulatory readiness... ...with multidisciplinary teams to optimize drug development. The ideal candidate will hold...SeniorFlagship Ventures
Cambridge, MA1 day ago- Dormont Manufacturing Co is seeking a Senior Director, Head of Medical Review for its Boston, MA office. The candidate will oversee medical... ...assessments and ensure compliance with regulations in pharmacovigilance. With a strong focus on leadership and strategic oversight,...SeniorWork at office
- Moderna seeks a seasoned scientific leader for a senior leadership role in Nonclinical Safety Evaluation. This position involves providing strategic leadership for Toxicology and Pathology, ensuring compliance with nonclinical safety standards for regulatory submissions...Senior
$196.7k - $353.4k
...are seeking a seasoned scientific leader to serve in a senior leadership role within Nonclinical Safety Evaluation, providing strategic and operational... ...therapeutics, oncology, and/or infectious disease vaccine drug development.* Experience serving in and/or managing colleagues...SeniorWork from home$180k - $270k
Vertex Pharmaceuticals in Boston is seeking a Pathology Senior Principal Research Scientist to lead scientific efforts in drug safety assessment. This role involves managing pathology endpoints and working closely with diverse teams to ensure the robustness of pathology...Senior- Scorpion Therapeutics in Boston is seeking a Patient Safety Associate Medical Director to provide medical safety expertise and pharmacovigilance for various products. Responsibilities include leading safety risk management and monitoring benefit-risk profiles to ensure...SeniorRemote job2 days per week
- Liberty Mutual Insurance is seeking a Technical Director for Industrial Hygiene and Engineering Services. This role involves developing strategies to manage workplace hazards and improve safety engineering protocols. The ideal candidate will have significant consulting...SeniorRemote job
- AstraZeneca is looking for a Global Safety Program Lead, Senior Director in Boston, MA. This role requires extensive leadership in safety strategy, managing a team of safety physicians and scientists while ensuring compliance with regulations. The ideal candidate should...Senior
- A leading biotech firm in Cambridge is seeking a Senior Product Manager to oversee Clinical Safety and Pharmacovigilance Systems. This role requires 7+ years in the biotech field, with an emphasis on system management and compliance. The successful applicant will work closely...Senior
- Moderna is seeking a seasoned scientific leader for a senior role in Nonclinical Safety Evaluation. The successful applicant will provide strategic leadership for Toxicology and Pathology, overseeing nonclinical safety strategies to support regulatory submissions. This...Senior
- A leading biotechnology company in Cambridge seeks a seasoned scientific leader for a senior role in Nonclinical Safety Evaluation to oversee Toxicology and Pathology. The candidate will guide a high-performing team, provide strategic leadership in nonclinical safety strategies...Senior
$275k - $300k
Centessa Pharmaceuticals is seeking a Senior Director, Toxicology in Boston, MA, to lead the development of nonclinical safety strategies for CNS programs. This role involves managing... ...pharmaceutical R&D, particularly within CNS drug development. The salary range for this full-...SeniorFull time- Moderna is seeking a seasoned scientific leader for a senior role in Nonclinical Safety Evaluation in Cambridge, MA. This role involves strategic leadership... ..., particularly in nucleic acid-based therapies and drug regulations. Benefits include best-in-class healthcare...Senior
- Moderna is seeking a Senior Product Manager - Clinical Safety and Pharmacovigilance Systems to oversee the digital product strategy and lifecycle management of critical platforms. You will ensure system reliability and enhance compliance while driving innovative AI/ML...SeniorWork at office
$233k - $315k
...rare patients. Position Summary The Senior Director, Medical Monitor & Safety Physician is a clinical and safety... ...with Clinical Development, Pharmacovigilance, Clinical Operations, Regulatory,... ...‑Functional Collaboration Provide drug safety leadership within matrix teams...SeniorTemporary workRemote workTravere Therapeutics
Boston, MA13 hours ago- ...Executive Medical Director, Drug Safety About the Company Highly regarded biopharmaceutical company Industry Biotechnology... ...scientists, and ensuring compliance with drug safety and pharmacovigilance regulations. The Executive Medical Director will also be...
Confidential
Boston, MA1 day ago $145.9k - $234.2k
The Role: Moderna is seeking a Senior Product Manager - Clinical Safety and Pharmacovigilance Systems to support the digital product strategy, operations, and lifecycle management of the platforms that enable our global Patient Safety and Pharmacovigilance functions. As...SeniorPermanent employmentWork at office$126k - $190k
...Responsibilities Managing safety scientist activities across multiple product portfolios... ...fellows Supporting activities related to new drug applications and other regulatory filings... ...in collaboration with GPS Medical Directors Performing Signal Surveillance activities...Temporary workDormont Manufacturing Company
Boston, MA13 hours ago$130k
...Overview: The Lemartec Senior Safety Manager is responsible for promoting and ensuring site safety and has a comprehensive knowledge... ...children Diabetes Management, Telehealth Coverage, Prescription Drug Plan, Pet Insurance Family & Lifestyle Paid Time...SeniorTemporary workFor contractorsWork experience placementFor subcontractorWork at officeLocal areaFlexible hoursLemartec Corporation
Boston, MA3 days ago$40 - $45 per hour
...seeking On-Call Emergency Managers to lead disaster response efforts across the US. Candidates should have a Bachelor's degree in Safety or Emergency Management and significant leadership experience. The role includes managing operations during disasters and ensuring...SeniorHourly pay$100k - $141k
Suffolk in Boston is seeking a Safety Manager to oversee compliance with safety policies on various project sites. Candidates should have 3-5 years of experience in construction health and safety and a willingness to achieve CHST designation. The role involves conducting...Senior- ...for people with serious diseases. We are seeking a Senior Manager to join our Patient Safety team. The Senior Manager of Global Patient Safety (GPS... ...guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marking...SeniorWorldwide
Regeneron Pharmaceuticals
Cambridge, MA1 day ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Director, Drug Safety & Pharmacovigilance. Be the first to apply!
- senior safety manager Boston, MA
- functional safety manager Boston, MA
- facility safety manager Boston, MA
- safety manager Boston, MA
- safety supervisor Boston, MA
- director of safety Boston, MA
- quality environment health safety manager Boston, MA
- environmental health & safety (ehs) manager Boston, MA
- drug safety manager Boston, MA
- occupational health and safety manager Boston, MA