MSD Pharmacovigilance Lead 

Spain, Community of Madrid, Madrid 

28496988

Job Description

Key Responsibilities:

• Lead the strategic planning and implementation of pharmacovigilance objectives in your country, including department structure, processes, and local Health Authority policy implementation.
• Manage and develop local resources, including recruitment, training, and performance management.
• Serve as the local Contact Person for Pharmacovigilance (CPPV) and ensure compliance with all local laws and regulations.
• Oversee daily pharmacovigilance processes and activities, collaborating with internal teams and external parties as necessary.
• Ensure that adverse experiences and product quality complaints are reported in compliance with corporate policies and procedures.
• Ensure that all required trainings are completed by the PV team and maintain the local training matrix and onboarding plans.
• Coordinate the translation of pharmacovigilance documents and ensure quality control checks.
• Maintain the filing, storage, and archiving of safety-related documentation in accordance with company policies and local requirements.
• Participate in compliance activities and coordinate the preparation of necessary documents for deviations from internal policies and procedures .
• Ensure audit / inspection readiness, coordinates, leads, and actively participates in local audits and inspections.
• Develop and maintains local Pharmacovigilance controlled documents.
• Identify procedural gaps and implement solutions in collaboration with stakeholders.
• Responsible for ensuring appropriate implementation and oversight of Additional Risk Minimization Measures locally.
• Act as a subject matter expert on relevant pharmacovigilance regulations, processes, and procedures.
• Collaborate with internal stakeholders to ensure compliance with pharmacovigilance requirements for new initiatives and programs.
• Provide expertise in the planning, execution, and maintenance of major projects.
• Represent pharmacovigilance in cross-functional forums and serve as a local expert on PV regulations.
• Participate on local company committees and councils (as appropriate) for matters impacting PV.

Requirements:

• Health, life science, or medical science degree or equivalent.
• At least 15 years of experience in the pharmaceutical industry with a focus on safety and pharmacovigilance activities.
• Experience in supervising and managing people.
• Strong leadership, communication, decision-making, and problem-solving skills.
• Detailed knowledge of adverse event reporting requirements, PV regulations, and PV quality management systems.
• Experience with PV audits and/or Health Authority inspections.
• Fluency in English and proficient in Spanish
• Ability to travel within the region and globally.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

Job Posting End Date:07/09/2024

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.