Manager, Pharmacovigilance

Responsible for proactively managing PV Vendor and Case Processing deliverables and activities in accordance with applicable regulations and agreements. Responsible for successful conduct of case processing activities for all investigational and marketed products to ensure timely processing of adverse events reports in compliance with health authority guidance, SOPs and/or PV agreements with partners.

• Evaluates all adverse event reports received from the case processing vendor for accuracy and regulatory reporting.
• Monitors case finalization work stream and prepares reports for distribution.
• Supports the preparation of all periodic reports for development and marketed products.
• Works effectively with external departments and License Partners on relevant PV deliverables (ex. works with Medical Affairs on post-marketing studies/programs)
• Exercises independent judgment in managing case processing PV deliverables and maintaining compliance with SOPs, licensed partner agreement and applicable worldwide regulations to ensure timely and consistent deliverables
• Assists with development and maintenance of applicable SOPs and Working Instructions.
• Frequently interacts with individuals at various management levels, including senior management, within and outside the organization to support vendor management and case processing deliverables. Interaction typically requires the ability to gain cooperation of others, conducting presentations of PV related information concerning specific projects or schedules.

Competencies

• Demonstrates strong ability to communicate effectively, both written and oral and sound attention to detail
• Exhibits ability to multi-task effectively
• Ability to complete work in a resourceful, self‑sufficient manner while maintaining a strong mentality
• Ability to analyze, interpret, and summarize moderately complex data with general oversight
• Exhibits firm comprehension of established procedures
• Applied understanding of industry practices for drug development and pharmacovigilance
• Possesses computer skills to support use of electronic systems and development of writing deliverables
• Working knowledge of pharmacovigilance database (e.g. Argus)

• BA/BS degree in life sciences
• Experience in the pharmaceutical industry with at least three to five years pharmacovigilance experience.
• Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments.
• Experience with and demonstrated success in working on cross-functional teams.