Job Description
The Senior Specialist, PV-PSM is responsible for management of all Company relationships, including business development partners, third-party vendors/suppliers, and emerging data sources. May be responsible for negotiation and maintenance of business partner and vendor PV agreements. May be responsible for the negotiation of safety management plans (SMPs) with Company CRO partners and PV Plans.
Key Responsibilities
Contribute to and provide subject matter expertise for PV templates for business development partners, third-party vendors/suppliers, and emerging data source deals to ensure compliance with integral PV regulations.
- Under the direction of the Executive Director/Director/Associate Director, Pharmacovigilance (PV) Partner Strategy & Management (PV-PSM), organizes, conducts and/or facilitates meetings with business development partners, CRO partners, third-party vendors/suppliers and internal stakeholders for the negotiation, implementation and maintenance of PV agreements, PV plans, and SMPs.
- Leads due diligence, capability assessments,
and compliance review of partners and third-party vendors/suppliers.
- Maintains PV global standards for relevant activities to ensure compliance and quality of PV requirements.
- Develops and maintains the necessary processes to ensure high quality individual case and aggregate safety reporting in accordance with pharmacovigilance (PV) policy and regulations.
- Creates and implements appropriate training as applicable in regard to new processes for each PV agreement.
- Provides support for inspections and audits related to Company partnerships.
- Collaborate with the system owner for the maintenance of the Business Development Lifecycle Management system.
Core Responsibilities
- Participate in interdepartmental and interdivisional meetings in support of individual program reviews, input for PV requirements, and related processes.
- Collaborate inter-divisionally to ensure PV requirements are incorporat
📌 Sr. Spclst, Drug Safety (Bogotá)
🏢 Msd
📍 Bogotá