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.