Sr Manager Safety and PSMF Coordinator (Temp)

Regeneron is seeking a Senior Manager for our QPPV operations department. The individual will play a key role in supporting the creation and maintenance of our Pharmacovigilance System Master File (PSMF) and all corresponding documents and annexes and local variations where required by local legislation. The position will support fulfilling requests for PSMF derivatives from impacted countries.,

• Collaborating with our team to support global and local literature screening processes to identify and assess safety signals..
• Actively participate in process improvement initiatives e.g., the development and maintenance of relevant SOPs, WIs and supporting documents
• Scheduling QPPV Oversight meetings, ensuring subject matter experts are present at QPPV oversight meetings, collating metrics/data for presentation at QPPV oversight meeting,
• Scheduling ad-hoc meetings with key partners where required, taking meeting minutes.
• Facilitating and enhancing cross-functional communication with the QPPV Office and the global business
  
  You are knowledgeable about European pharmacovigilance legislation and the principles of global pharmacovigilance requirements.
• Possess a strong grasp of the EMA GvP module.
• You enjoy working on diversely complex matters that involve analyzing issues, data, and PV processes.
• Demonstrate exceptional initiative, creativity, and innovation skills.
• You have the ability to build and lead collaborative partnerships both within the organization and externally.
To be considered for this opportunity, you should hold a Bachelor's degree or equivalent experience. Proven previous experience of 8 years in pharmaceutical industry or regulatory authority, direct pharmacovigilance experience, preferably with pharmaceuticals and/or biologics. We need someone with proficiency in use of drug safety databases or equivalent with strong expertise in Microsoft Office. Willingness to operate in a diverse, international matrix environment.