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Associate Director, PV Partner Management, Clinical Safety & Pharmacovigilance

Basking Ridge, NJ 07920

Posted: 11/29/2022 Employment Type: Contract Job Category: Data Sciences Job Number: 524933 Is job remote?: No Country: United States

Job Description

Job Description:
This position manages DSI CSPV partnerships and contracts including vendor outsourcing agreements, partner contracts, and Pharmacovigilance Agreements (PVAs) / Safety Data Exchange Agreements (SDEAs).  Manage, negotiate, maintain & document collaborative & license partner safety agreements with counterparts from (license) partner companies. Management of relationships with Contract Partners involving PV provisions and PV Information Exchange in Contractual Arrangements to ensure good Pharmacovigilance practice and regulatory compliance in such arrangements. Oversees service providers responsible for Call Center, case processing for DSI products, both investigational and marketed, to ensure accurate assessment and timely reporting of safety information. Additionally this position is responsible for the management of PV regulatory intelligence, including dissemination, maintenance, and support of impact assessment of emerging global regulatory requirements. This position provides subject matter expertise and technical guidance on functional requirements to implements corrective and preventative actions to remediate non-conformance issues involving partners, CROs, and case processing vendors.

  • Communicates effectively within the team, cross-functionally, regionally and globally as applicable; demonstrates clear written communication skills with internal and external team/stakeholders.
  • Effectively manages shifting priorities; collaborates and communicates across functions to achieve critical priorities.
  • Possesses a comprehensive understanding of the functional roles for clinical safety and pharmacovigilance for investigational and marketed products.
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