Responsible for supporting PV Planning in the successful conduct of safety related activities supporting all stages (including late stage) clinical compounds in accordance with applicable GCPs and/or regulations. Supports process improvement initiatives. Frequently interacts with collaborators, and functional peer groups at various management levels. Interaction normally requires the ability to gain cooperation of others, conducting presentations of PV related information concerning specific projects or schedules (support of clinical programs).
- Serves as liaison for internal and external personnel for PV deliverables in clinical programs, generally supports Phase III & IV programs and/or Alliance Partners (AP).
- Works closely with Regulatory, Clinical Development, Data Management and Medical Affairs personnel.
- Exercises independent judgment in managing clinical program GPS deliverables and maintaining compliance with SOPs, AP agreements and applicable worldwide regulations to ensure timely and consistent deliverables.
- Leads and/or contributes to continuous improvement/quality system initiatives through evaluation, development and roll out of process efficiencies applicable to internal PV Planning deliverables.
- Ensures development and maintenance of applicable SOPs and Working Practices and training.
- Collaborates with Clinical Teams, CROs and Alliance Partners to ensure proper data reconciliation.
- Impact/ Discretion: Knows when to escalate an issue and applies critical thinking if timelines are at risk
This role might be for you if:
- Bachelor’s level degree in life sciences required (Pharmacy, Nursing or equivalent). Advanced degree preferred.
- Six or more years of Pharmacovigilance/Drug Safety or clinical experience in the pharmaceutical industry required.
- Demonstrated successful management and completion of a Phase I /II program(s) or project(s) of equivalent complexity.
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 outstanding benefits including health and wellness programs, fitness centers and stock for 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.