Job Title: Manager, PV Partner Management, Clinical Safety & Pharmacovigilance (CSPV)
Location/Schedule:
Job Description:
This position is responsible for overseeing PV regulatory intelligence, ensuring the dissemination, maintenance, and impact assessment of emerging global regulatory requirements. These requirements are collected from various sources, including the PV Regulatory Intelligence vendor, CROs, and others.
The Manager will collaborate with service providers responsible for Call Center operations and case processing for DSI products, both investigational and marketed, to ensure accurate assessment and timely reporting of safety information.
Additionally, this role will support DSI CSPV partnerships and contracts, including vendor outsourcing agreements, partner contracts, Pharmacovigilance Agreements (PVAs), and Safety Data Exchange Agreements (SDEAs). The Manager will manage, maintain, and document collaborative & license partner safety agreements with counterparts from license partner companies.
Key responsibilities include managing relationships with Contract Partners to ensure good Pharmacovigilance practice and regulatory compliance in PV provisions and PV information exchange within contractual arrangements. This position will also provide subject matter expertise and technical guidance on implementing corrective and preventative actions to resolve non-conformance issues involving Reg Clients, partners, CROs, and case processing vendors.
Key Qualifications:
Candidate Requirements:
Candidates should highlight their experience in PV Operations and Systems, PV Agreements, and contracts, as well as their knowledge of PV regulatory intelligence.
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