Regeneron Pharmaceuticals Associate Director, Clinical PV Operations in Tarrytown, New York
Responsible for the oversight of safety reporting activities for clinical programs in accordance with FDA and international regulations, guidances and guidelines, and Regeneron policies and procedures. Responsible for management of personnel assigned to these activities.
Lead a group responsible for oversight of vendor(s) providing safety reporting activities for global safety submissions.
Oversee preparation of safety management/ regulatory reporting plans to ensure appropriate plans are in place, consistent, accurate, and being followed. Responsible for other Clinical PV Operationss deliverables as needed
Act as primary Clinical PV Operations contact with vendor(s) providing safety reporting activities.
Responsible for management of other Clinical PV Operationss personnel providing oversight of safety reporting vendor(s); this includes but is not limited to management of job performance, career development and training.
Leads continuous improvement/quality system initiatives through evaluation, development and roll out of process efficiencies applicable to all Clinical PV Operationss deliverables whether internal or external to the department.
Well informed on relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments required.
Experience with managing direct reports on complex projects. Demonstrated success in working on cross-functional teams in a leadership role.
Minimum Years of Experience:
Pharmacy, nursing or equivalent required, advanced degree preferred.
Previous Pharmacovigilance/Drug Safety experience in pharmaceutical / biotech industry required; typically with 9 + years (7 + years if Master’s Degree) of Pharmacovigilance/Drug Safety experience.
Demonstrated successful management and leadership on projects of complexity.
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron’s unwavering commitment to combining good science & good business.
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