Director, Safety Physician, Global Pharmacovigilance
Klein Hersh
Our client's vision to transform the way we understand and treat the most challenging medical conditions of our time, including cancer, autoimmune disorders and infection. The Safety Physician, Global Pharmacovigilance, should be a physician with training and experience in Pharmacovigilance and Risk Management in the pharmaceutical/biotech industry to contribute to the overall medical oversight and safety evaluation within Pharmacovigilance and Risk Management. This position is responsible for the proactive and timely risk-benefit assessments of safety data to characterize the emerging and known safety profiles of development and marketed company products. The Safety Physician assists in the successful development, execution and maintenance of safety-related strategies, processes and systems that conform to the company's business strategy, industry standards and compliance with global regulations. This individual will provide guidance to third party vendors and to internal/external staff in the collection, evaluation and processing of adverse events from clinical trials and postmarketing surveillance. This role provides an excellent opportunity to collaborate closely with colleagues from other functions such as Clinical Development, Clinical Operations, Regulatory Affairs and Medical Affairs. Job Responsibilities Conduct medical review of individual case safety reports (ICSRs) including identification of appropriate follow-up requests of important medical information for the proper medical assessment and evaluation of cases. Responsible for the review and communication of safety data trending, signalling and other safety related issues originating from any source for the purpose of detecting and reviewing safety signals in a timely manner via the Safety Governance process. Responsible for the development of review/response documents for safety issues arising from internal review or regulator feedback. Chair the multidisciplinary Safety Management Team whose responsibilities include safety surveillance (signal detection and evaluation), risk management planning, and making recommendations related to safety issues Participate in the preparation and maintenance of Reference Safety Information (RSI) and product labeling (e.g. Company Core Safety Information (CCSI), Investigator Brochure (1B), national labels), Risk Management Plans (RMP). Collaborate with key stakeholders including business partners in appropriate safety analyses and risk assessment and management strategies. Author medical-safety sections of aggregate safety reports (DSUR, PBRER) Participate in development of safety-related responses to queries from Regulatory Authorities Maintain knowledge of disease and therapeutic areas for marketed products and products in development Demonstrate knowledge and ensure compliance with applicable global PV regulations and guidelines (e.g. CIOMS, FDA, EMA, ICH, etc.). Job Requirements M.D./D.O Degree Experience in Pharmacovigilance, particularly with individual case review and evaluation. Experience with concepts of signal detection and review of aggregate data to identify potential emerging safety issues, benefit risk assessment, and risk management strategies. Knowledge of clinical development process Experience in the preparation and contribution to authoring of aggregate safety reports for regulator submission. Demonstrated ability to prioritise multiple tasks and deliver to deadline with high standard of quality. Experience with commercially available safety databases. At least three years of practical clinical experience post licensure At least three years of pharmacovigilance experience Knowledge of drug approval process in major countries. #J-18808-Ljbffr
$205k - $341.6k
...The Global Patient Safety (GPS) Lead role (Director of GPS) serves as the first point of contact (POC) for all safety related issues for the compound... ...guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing...SuggestedLocal area$249.97k - $388.13k
Otsuka Pharmaceutical Co., Ltd seeks a Senior Director of Global Medical Safety Physician in the United States, primarily focusing on psychedelic compounds. This role demands a strategic leader in pharmacovigilance, guiding the safety teams and influencing safety strategies...Suggested- ...Senior Director, Drug Safety & Pharmacovigilance About the Company A well-funded, clinical-stage biotechnology company focused on autoimmune and... ...Director of Drug Safety and Pharmacovigilance to lead global safety and pharmacovigilance activities, ensuring compliance...Suggested
$233k - $315k
...Diego, USA- Remote Be a part of a global team that is inspired to make a... ...Position Summary: The Senior Director, Medical Monitor & Safety Physician is a clinical and safety leader... ...partnership with Clinical Development, Pharmacovigilance, Clinical Operations, Regulatory,...SuggestedTemporary workRemote work- ...Executive Medical Director, Drug Safety About the Company Highly regarded biopharmaceutical... ...compliance with drug safety and pharmacovigilance regulations. The Executive Medical Director... ...Hiring Manager Title SVP, Global PV & Risk Management Functions...Suggested
$285.6k
...science and innovation to develop life‑changing medicines for people with serious diseases. We are seeking an Executive Director, Global Patient Safety Sciences Delivery to lead Patient Safety operations across all Therapeutic Areas. When & Where Work Location:...$285.6k
BioSpace is seeking an Executive Director for Global Patient Safety Sciences Delivery to join their team in New Jersey. This role involves overseeing... ...degree along with at least 17 years of experience in pharmacovigilance. The position offers a hybrid work model and a...- A leading pharmaceutical company is seeking a Safety Physician in Pennsylvania. The role focuses on pharmacovigilance and risk management, involving medical review of safety data and collaboration with various teams. Candidates must hold an M.D./D.O Degree and have experience...
$150.5k - $245.5k
...We are seeking a Senior Manager to join our Patient Safety team. The Senior Manager of Global Patient Safety (GPS) will play a key scientific role... ...ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post‑...- ...while transforming your career. Global Safety Officer, Medical Director, Rare Disease What you will do Let... ...strategy, direction, and priorities of pharmacovigilance activities and are accountable... ...with a dynamic team of safety physicians and scientists dedicated to bringing...Private practiceRemote workFlexible hours
- A leading clinical research organization is seeking an experienced Global Patient Safety Scientist to manage safety strategies for clinical development products. This role requires a Master's, PhD, or PharmD, alongside at least 5 years of relevant experience in the pharmaceutical...Full time
$178.5k - $297.5k
## Global Safety OfficerBewerbenlocations: Cambridge, MA: Morristown, NJtime type: Vollzeitposted on: Heute ausgeschriebentime left... ...into development plans* Support due diligence activities and pharmacovigilance agreements**Signal Detection & Assessment*** Responsible...Work experience placement- Chiesi Farmaceutici S.p.A. is hiring a Clinical Research Physician for Global Rare Diseases. This role supports clinical teams and oversees global studies while interfacing with scientific experts. The ideal candidate will have over 2 years of experience, especially in...Remote job
- # Associate Director/ Senior Manager / Manager - Global Patient Safety Scientist##### Overview| || --- || **Position Summary** **Summary** Global patient safety... ..., initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing...
$156.31k - $214.93k
Associate Director, Consumer Safety ScienceSkip to main content#Associate Director, Consumer Safety Science page is loaded## Associate Director... ...experience in similar role with extensive knowledge in pharmacovigilance.* In-depth knowledge in causality assessment, evaluation...Work at office3 days per week- MSD Malaysia is seeking a Director of Global Regulatory Affairs & Clinical Safety to lead regulatory efforts in business development initiatives. This role will oversee staff and manage various regulatory components crucial to agreements involving product acquisitions and...
- ...serious diseases. We are seeking an Associate Director, PV Case Operations to join our Global Patient Safety team, supporting case processing across global... ...advanced degree preferred. Typically 10 years of Pharmacovigilance, Drug Safety, or PV Quality experience in...Worldwide
- Initial Therapeutics, Inc. is looking for an Executive Director for their Patient Safety team to lead Global Patient Safety Sciences delivery. The role involves driving consistency across safety operations, overseeing compliance, and ensuring quality management while contributing...
$110k - $120k
...Hygiena is seeking a Global Market Development Manager to join our team remotely in the United States. This full-time position requires expertise in food safety and regulatory affairs, along with a Master’s or Ph.D. in a related field. Responsibilities include representing...Full timeRemote work- Zuma Restaurants is seeking a Facilities Manager to ensure our establishment meets operational, safety, and regulatory standards. This role involves managing daily maintenance operations, coordinating with external contractors, and ensuring a safe environment for all....For contractors
- REMOTE Opportunity with a global corporation. Person can live anywhere in the country. The EHS Director is responsible for the strategic vision, implementation, and continuous... ...improvement of all environmental, health, and safety programs across manufacturing operations. This...Permanent employmentLocal areaRemote work
- Director, Health, Safety & Environment (HSE) - U.S. At Mobius Renewables, we’re transforming waste into renewable energy and measurable decarbonization. We’re a new global, vertically integrated low carbon fuels platform established to accelerate the development, production...For contractorsWork at officeLocal area
- TechBrains is seeking an experienced EH&S Program Manager to build and oversee a comprehensive health and safety program. This role involves strategic planning and management of health and safety initiatives, compliance, and risk management, ensuring employee safety across...
- ...Position Overview At Houston Methodist, the Manager Public Safety/Security position is responsible for managing security operations... ...for essential functions Effective communication across patients, physicians, families, and coworkers with a customer-service focus Strong interpersonal...Shift work
- TikTok is seeking a skilled communications professional to enhance its Global Trust & Safety team in New York. The ideal candidate will take charge of crafting impactful communication plans targeting the safety of teenagers while ensuring compliance with global regulations...
- A leading life sciences software company is seeking a Senior Consultant to join the Safety Professional Services team. This role involves the implementation of Vault Safety, where you will take on responsibilities as both Project Manager and Solution Architect. Candidates...Remote job
$160k - $175k
ABOUT THE TEAM: The Redefining Public Safety (RPS) Initiative at the Vera Institute of... ...ABOUT THE ROLE: The RPS Initiative Director will be responsible for the overall direction... ...increasingly multicultural country and globally connected world. We value diverse...Full timeWork experience placementWork at officeLocal areaFlexible hours- Manager, Pharmacovigilance Safety Operations Our client, a Clinical-Stage Cell Therapy company, is looking for a Manager, Pharmacovigilance Safety Operations for their Bothell, WA/CA/Remote location. Responsibilities: Represent Patient Safety as a Study Management Team...Remote work
- ...leading staffing agency in the United States is seeking a Senior Project Manager to lead the strategic build-out of their offshore IT Global Capability Center. This high-impact role requires 8+ years of project management experience, with a proven success in global...
$285.8k - $365.8k
Position Summary BeOne’s Global Patient Safety (GPS) leadership team seeks a seasoned professional to lead end‑to‑end execution, quality... ...reports (ICSRs), safety operations in clinical trials, China pharmacovigilance activities, and safety systems. It also actively supports...Work at office
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Director, Safety Physician, Global Pharmacovigilance. Be the first to apply!
- product safety manager New York, NY
- senior safety manager New York, NY
- functional safety manager New York, NY
- facility safety manager New York, NY
- safety compliance manager New York, NY
- safety manager New York, NY
- safety manager construction New York, NY
- safety supervisor New York, NY
- director of safety New York, NY
- quality environment health safety manager New York, NY

