R&D MD VP

Who You Are

The VP of Drug Safety will be responsible for managing all aspects of the drug safety functions of the CROs and will be an integral part of the Safety Management Team. In addition, they will be responsible for collaborating with Clinical Operations, QA, Clinical Research, Regulatory Affairs, Medical Information/Liaisons, and Medical Writing for investigational compounds across the company. Responsibilities can grow to include marketed product safety and pharmacovigilance when appropriate.

Responsibilities

• Contribute to and lead a full range of pharmacovigilance (PV) activities for investigational products, including operational activities, cross-functional activities with other departments, quality systems, audits, and inspections
• Direct drug safety management oversight (clinical study case process flow, reconciliation with clinical database) for specific clinical trials, as requested
• Manage oversight of external activities by vendors (CROs), including case processing, expedited safety reporting, and partner data exchange. The successful candidate will be responsible for oversight of safety operations strategy, including case management, database strategy, vendor oversight, compliance, inspection readiness, contracts, and training
• Lead Safety section of submission documents
• Participate and/or lead presentations with Regulatory Authorities
• Participate and/or lead meetings with consultants and investigators
• Participate and/or lead advisory panel meetings
• Contribute to and review safety data exchange agreements with alliance partners and safety management documentation for studies managed under an alliance, as applicable
• Develop proactive risk management strategies for investigational compounds
• Provide updates of the assigned drug’s safety profile to senior management and recommend pharmacovigilance/risk management activities
• Contribute to and review investigator’s brochures, safety sections of clinical study protocols, single and aggregate expedited reports, areas of regulatory submissions, or regulatory responses (including IRBs or Ethics Committees)
• Plan, manage/perform