Manager, Pharmacovigilance Vendor & Case Processing Management - Regeneron - Tarrytown, NY

Manager, Pharmacovigilance Vendor & Case Processing Management - Regeneron - Tarrytown, NY -

Recognized for its scientific and operational excellence, Regeneron is a number one science-based mostly biopharmaceutical firm that discovers, invents, develops, manufactures, and commercializes medicines for the remedy of great medical circumstances. Regeneron commercializes medicines for eye illnesses, excessive LDL-ldl cholesterol, and a uncommon inflammatory situation and has product candidates in improvement in different areas of excessive unmet medical want, together with oncology, rheumatoid arthritis, bronchial asthma, atopic dermatitis, ache, and infectious illnesses.

Abstract:
Chargeable for proactively managing routine Vendor Management and Case Processing deliverables and actions in accordance with relevant laws and agreements. Liable for profitable conduct of case processing actions for all investigational and marketed merchandise to make sure well timed processing of antagonistic occasions stories as described within the FDA Code of Federal Laws, Regeneron Licensing Companions Security Knowledge Trade Agreements and SOPs. Helps new/ongoing part IV/post-marketing research

Duties:
1. Serves as a main level of contact with vendor for managing routine actions and addressing associated points
2. Serves as level of contact with PVRM senior management for updates and well timed escalation of points that require senior management consideration.
three. Evaluates all antagonistic occasion studies acquired from the case processing vendor for accuracy and regulatory reporting. Screens case finalization work stream and prepares reviews for distribution.
four. Identifies and leads course of enchancment actions whether or not inner to group or PVRM; or involving teams exterior to PVRM or Regeneron, together with distributors or License Companions.
5. Works successfully with exterior departments and License Companions on related PV deliverables (ex. works with Medical Affairs on post-marketing research/packages).
6. Workouts unbiased judgment in managing case processing PV deliverables and sustaining compliance with SOPs, LP settlement and relevant worldwide laws to make sure well timed and constant deliverables.
7. Ensures improvement and upkeep of relevant SOPs and Working Directions and coaching.
eight. Could also be answerable for management of assigned personnel.

Works on issues of numerous scope which require evaluation of state of affairs or knowledge. Determines and pursue programs of motion crucial to acquire desired outcomes. Workouts judgment inside usually outlined practices and insurance policies in choosing strategies and methods for acquiring options.

Incessantly interacts with people at numerous management ranges, together with senior management, inside and out of doors the group to help vendor management and case processing deliverables. Interplay sometimes requires the power to realize cooperation of others, conducting shows of PV associated info regarding particular tasks or schedules.

Necessities:

• Capacity to use related FDA, EU and ICH tips, initiatives and laws governing pharmacovigilance actions for each medical trial and post-marketing environments required.


• Act as material skilled in case processing and as a useful resource on related FDA, EU and ICH tips, initiatives and laws.


• Expertise with and demonstrated success in engaged on cross-useful numerous groups required.


• Demonstrated management of tasks or groups.

Schooling & Expertise:

• Bachelor’s degree diploma in life sciences required. Pharmacy, nursing or equal required, superior diploma most popular.


• Earlier related expertise within the pharmaceutical business required; sometimes 10+ years with Bachelors diploma, 7+ with Masters diploma, and 5+ with superior diploma (ex. PharmD).


• Demonstrated profitable management and management of tasks related to scope of this place.

This is a chance to hitch our choose group that’s already main the best way within the Pharmaceutical/Biotech business. Apply at present and study extra about Regeneron’s unwavering dedication to combining good science & good enterprise.

To all businesses: Please, no telephone calls or emails to any worker of Regeneron about this opening. All resumes submitted by search companies/employment businesses to any worker at Regeneron by way of-e-mail, the web or in any type and/or technique can be deemed the only property of Regeneron, until such search companies/employment businesses have been engaged by Regeneron for this place and a legitimate settlement with Regeneron is in place. Within the occasion a candidate who was submitted outdoors of the Regeneron company engagement course of is employed, no charge or cost of any type will probably be paid.

Regeneron is an equal alternative employer and all certified candidates will obtain consideration for employment with out regard to race, colour, faith, intercourse, nationwide origin, sexual orientation, gender id, incapacity standing, protected veteran standing, or another attribute protected by regulation.

APPLY THIS JOB HERE