Overview
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. This may include negotiation and maintenance of PV agreements, and safety management plans (SMPs) with Company CRO partners and PV Plans.
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), organize, conduct 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.
- Lead due diligence, capability assessments, and compliance review of partners and third-party vendors/suppliers.




- Maintain PV global standards for relevant activities to ensure compliance and quality of PV requirements.
- Develop and maintain processes to ensure high quality individual case and aggregate safety reporting in accordance with PV policy and regulations.
- Create and implement appropriate training regarding new processes for each PV agreement.
- Provide support for inspections and audits related to Company partnerships.
- Collaborate with the system owner for the maintenance of the Business Development Lifecycle Management system.
- Participate in interdepartmental and interdivisional meetings to support program reviews, PV requirements, and related processes.
- Collaborate inter-divisionally to ensure PV requirements are incorporated into business processes, standards, and resources.
- Identify, prioritize, and monitor quality issues to maintain compliance.
- Develop and support processes that facilitate achievement o

📌 Sr. Spclst, Drug Safety (Bogotá)
🏢 Msd Malaysia
📍 Bogotá