Executive Director/VP Safety and Pharmacovigilance
Location
Carlsbad, CA | United States
Job description
Our client is looking to fill the position of Executive Director/ VP Safety and Pharmacovigilance. This position is hybrid and bases out of the Carlsbad office. Oversight for the clinical safety strategy for assigned drug projects and products, provides drug safety expertise and guidance to Clinical Development, Safety Committee, and the Clinical Project Teams, and drives proactive implementation of risk management initiatives in accordance with global regulatory requirements.
Responsibilities:- Major areas of responsibility include continuous efficient evaluation of safety data to perform signal evaluation and predict and manage the safety profile of compounds in clinical development, consistent communication of safety topics across all regulatory safety documents, and strategic collaboration with company partners.
- Leads product risk characterization and benefit/risk assessment activities encompassing proactively identifying through individual case review reports or aggregate reviews new signals, and evaluating the signals and providing risk minimization measure, and communicating those issues through Head of Safety
- Ability to put together coherent risk assessment and mitigating strategies and present with set of recommendations to the Safety Oversight Committee for feedback and endorsement
- Lead risk management and risk mitigation activities, including medical and safety
- Provides medical input into identification and utilization of appropriate sources of information and database searches to retrieve relevant data for evaluation of signals
- Proactively evaluates the clinical implications of safety data from pre-clinical studies, clinical studies, literature, and other information sources to predict/establish the safety profile of compounds in clinical development
- Accountable for medical content and safety messaging in aggregate reports (PBRERs, DSURs, IBs) and responses to Health Authority requests, as well as capability in offering medical judgment on complex safety issues
- Participates in SOP updates, audits, and inspection readiness
- Writes/reviews and provides technical input for the safety sections of regulatory documents for assigned projects (i.e., protocols, IBs, ICFs, CSRs, IND submissions, annual reports, etc.)
- Participates in external regulatory and non-regulatory meetings, including those with consultants and other companies, such as licensing partners
- Provide clinical education support for internal company customers
- Collaborates effectively in cross-functional and cross-cultural project teams and environments, and work with external providers
- Managerial responsibilities include managing other physicians within the group
Required Qualifications: - Medical degree (e.g., MD, MBBS)
- At least 5 years of safety experience post-registration and overall 15yrs of pharma safety experience
- People management experience with a minimum of 5+yrs
- Extensive experience supporting safety filing activities, or leading activities in signal detection and supporting aggregate reports (DSUR, PADERs & PBRERs)
- Experience submitting reports of periodic review of aggregate safety data to Health Authorities in the US, UK and Republic of Ireland
- Safety experience supporting NDA/MAA submissions
If you meet the required qualifications and are interested in this role, please apply today.
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