Summary The Vice President of Drug Safety will oversee all activities and deliverables of the Drug Safety Department. This includes providing operational and medical oversight for safety activities related to all medicinal products, ensuring compliance with regulatory requirements, and driving risk management strategies throughout the product lifecycle. The role involves supervising and mentoring the Drug Safety team, collaborating with other department heads, and providing quality oversight to safety service providers.
Responsibilities:
Manage the receipt, processing, review, and reporting of adverse events.
Oversee the review and interpretation of aggregate safety data and its impact on clinical programs.
Lead the signal management system, including detection, evaluation, and management of safety signals.
Serve as the senior safety advisor on project and product teams.
Collaborate with regulatory affairs on safety labeling updates.
Ensure compliance with SOPs, policies, regulations, and laws.
Provide oversight on safety service providers' work.
Lead and develop the Drug Safety team, setting performance standards and managing performance.
Work closely with the Business Development department on safety data disclosure for partnerships.
Requirements:
MD degree with 15+ years of experience in drug safety/pharmacovigilance.
In-depth knowledge of drug safety practices and regulations.
Direct experience with Oncology is a must**
Proven leadership capabilites with an open door policy
Strong organizational, management, and communication skills.
Ability to work effectively in a fast-paced environment and think creatively.