Executive/Senior Director, PV & Drug Safety - Medical Safety and Risk Management
Executive/Senior Director, PV & Drug Safety - Medical Safety and Risk Management 2007963
Location: Boston, MA (Remote)
Therapeutic Areas: Undisclosed
Job Overview: This job involves leadership in Drug Safety Pharmacovigilance, building and managing a Medical Safety and Risk Management team, overseeing safety and benefit-risk assessment of clients products, ensuring regulatory compliance, and collaborating with various departments in the organization.
- Build and manage Medical Safety and Risk Management team consisting of safety physicians and safety scientists.
- Responsible for signal management, risk management, and benefit-risk assessment of all products throughout the product lifecycle from First-In-Human to post-marketing.
- Provide strategic leadership in safety surveillance for clinical development programs and lead the safety perspective in NDA submissions.
- Review safety data of non-clinical studies to inform clinical development strategies and plans, including dose escalation protocols.
- Medical degree (MD) required, with at least 2 years’ experience in clinical/medical practice.
- 15+ years’ experience in at global pharmaceutical or biotechnology companies, including 10+ years’ experience as a safety physician leading SMT in drug safety & pharmacovigilance for products in clinical trial and post-marketing environments.
- 5+ years’ experience as a people manager.
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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