Mgr Global Patient Safety

SUMMARY:

Responsible for proactively managing routine CERM 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 as described in the FDA Code of Federal Regulations, Regeneron Licensing Partners Safety Data Exchange Agreements and SOPs.

Supports new/ongoing phase IV/post-marketing studies.

JOB RESPONSIBILITIES:

• Serves as a primary point of contact with vendor for managing routine activities and addressing related issues.
• Serves as point of contact with PVRM senior management for updates and timely escalation of issues that require senior management attention.
• 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.
• Identifies and leads process improvement activities whether internal to group or PVRM; or involving groups external to PVRM or Regeneron, including vendors or License Partners.
• 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, LP agreement and applicable worldwide regulations to ensure timely and consistent deliverables.
• Ensures development and maintenance of applicable SOPs and Working Instructions and training.
• May be responsible for management of assigned personnel.
• Works on problems of diverse scope which require analysis of situation or data.
• Determines and pursue courses of action necessary to obtain desired results.
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• 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.

JOB REQUIREMENTS:

• Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.
• Act as subject matter expert in case processing and as a resource on relevant FDA, EU and ICH guidelines, initiatives and regulations.
• Experience with and demonstrated success in working on cross-functional diverse teams required.
• Demonstrated leadership of projects or teams.

Education

• Bachelor’s level degree in life sciences required. Pharmacy, nursing or equivalent required, advanced degree preferred.

Experience

• Previous relevant experience in the pharmaceutical industry required; some degree requirements may be waived due to extensive experience
• 10 plus years with Bachelor’s degree,
• 7 plus years with Master’s degree, and
• 5 plus years with advanced degree (ex. PharmD).