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Associate Dir, PV Strategic Mgmt & Reg Intel I

Basking Ridge, NJ 07920

Posted: 01/11/2023 Employment Type: Contract Job Category: Pharmacovigilance Job Number: 540104 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 50-100/hr **salary will be commensurate with experience 

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.

Skills:
  • 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.
Education:
  • Bachelor's Degree Nursing, Pharmacy, Life Sciences, Health Care or related field required or
  • Master's Degree Life Sciences preferred
  • PharmD Life Sciences preferred
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