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Associate Director – Pharmacovigilance Partner Strategy

MSD LATAM · Puerto Bogotá

Senior 🇬🇧 English

Job description

About the role

The Associate Director, Pharmacovigilance Partner Strategy & Management leads the safety oversight of all external collaborations, including business development partners, CROs, third‑party vendors and emerging data sources. This senior position drives negotiation, implementation and maintenance of pharmacovigilance agreements, safety management plans and cross‑divisional policies to ensure compliant, enterprise‑wide safety activities.

Key responsibilities

  • Organise and lead meetings with partners, CROs, vendors and internal stakeholders to negotiate and implement PV agreements, plans and safety management plans (SMPs).
  • Maintain internal guidelines for creating, updating and retaining PV agreements and SMPs in collaboration with senior PV leadership.
  • Oversee due‑diligence, capability assessments and compliance reviews of all partners and vendors.
  • Ensure accurate and complete transfer of safety data between the company and partners, coordinating with Pharmacovigilance Operations for data and algorithm updates.
  • Assess training needs related to new PV processes and develop appropriate training programs.
  • Own end‑to‑end implementation and maintenance of Global Clinical Safety & Pharmacovigilance (GCS&PV) activities for all business development and vendor agreements.
  • Serve as the primary PV contact for inspections and audits concerning partnerships.
  • Collaborate closely with Legal, Business Development, Procurement, Human Health and Alliance Management to enforce consistent global PV policies.

Required profile

  • Extensive knowledge of global pharmacovigilance regulatory requirements.
  • Proven experience negotiating and managing PV agreements and safety management plans.
  • Strong background in due‑diligence, compliance review and vendor assessment.
  • Ability to coordinate safety data transfers and ensure data integrity across systems.
  • Experience developing and delivering training on PV processes.
  • Excellent cross‑functional collaboration skills with legal, business development and procurement teams.

Required skills

  • Knowledge of global pharmacovigilance regulations.
  • Experience with safety data transfer and algorithm updates.
  • Familiarity with Business Development Lifecycle Management systems.

Questions fréquentes

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Published 2 months ago

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MSD LATAM

Puerto Bogotá