Sr Manager Safety and PSMF Coordinator

1 mese fa

Italia Regeneron A tempo pieno

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.
As a Senior Manager, your typical day might include:

  • 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.
This role might be for you if:
  • 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.
Does this sound like you? Apply now to take your first step towards living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

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