The role will support the Qualified Person(s) for Pharmacovigilance (QPPVs) and their deputies in maintaining and improving the global pharmacovigilance system.
A key responsibility will be to support creation and maintenance of the Pharmacovigilance System Master File (PSMF) and all corresponding documents and annexes and local variations where required by local legislation. The PSMF is required by European Union (EU) legislation and derivative expectations exist from regulatory authorities outside the EU. A ‘core’ PSMF will be maintained, and the position will support fulfilling requests for PSMF derivatives from impacted countries.
The position will also provide support for a multitude of activities supporting the global business including:
- Ensuring the QPPV has access to and regularly receives all information required to demonstrate oversight of the global pharmacovigilance (PV) system
- Support global and local literature screening process across Regeneron’s portfolio in collaboration with GPS stakeholders.
- Maintaining inspection readiness of the QPPV Office
- Actively participate in process improvement initiatives e.g., the development and maintenance of relevant SOPs, WIs and supporting documents
- Maintenance and oversight of the QPPV Office mailbox
- Scheduling QPPV Oversight meetings, ensuring subject matter experts are present at QPPV oversight meetings, collating metrics/data for presentation at QPPV oversight meeting, authoring meeting minutes, storing finalized minutes in secure SharePoint folder.
- Maintenance of the QPPV Office SharePoint site
- Scheduling ad-hoc meetings with key stakeholders where required and taking meeting minutes.
- Facilitating and enhancing cross-functional communication with the QPPV Office and the global business
Maintaining and improving the functioning and efficiency of the QPPV office. Proficiency in project management Understanding and ensuring the requirements for PSMF (global and local) are met. Understanding global and local literature screening process for pharmacovigilance across the Company’s portfolio for pharmacovigilance Participate in the development and maintenance of relevant SOPs, working practices & Business Process Tools Actively participate in process improvement activities within the global safety department
- Awareness of European pharmacovigilance legislation and the principles of global pharmacovigilance requirements including knowledge of PV quality systems and regulatory requirements across US and other countries and regions
- Knowledge of EMA GvP modules
- Works on diversely complex matters which may include analysis of issues, data and PV processes.
- Demonstrates exceptional initiative, creativity and innovation skills.
- Ability to build and manage collaborative partnerships internally and externally and work experience in pharmaceutical industry or regulatory authority, direct pharmacovigilance experience, preferably with pharmaceuticals and/or biologics.
- Strong technical and problem-solving skills/experience. Willingness to operate in a diverse, international matrix environment.
- An ability to contribute to a team environment.
- Excellent organizational and relationship management skills Excellent oral and written communication skills; technical writing capability.
- Proficiency in use of drug safety databases or equivalent with strong expertise in Microsoft Office
- 8+ years experience in pharmacovigilance
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.