Senior Pharmacovigilance Specialist

Opdrachtgever

Our client is a leading Project Management and Engineering company serving the pharmaceuticals industry around the world.

Degree in Life Sciences, Health Sciences, Pharmacy, Medicine, or a related discipline.
Minimum 2 years of experience in the pharmaceutical industry and/or Pharmacovigilance.
Strong knowledge of PV regulations, adverse event reporting requirements, quality systems, and inspection readiness.
Experience supporting PV audits and regulatory inspections.
Fluent in English and proficient in the local language.
Strong communication, stakeholder management, organizational, and project management skills.
Ability to work independently and effectively across functional and organizational boundaries.
Demonstrated ability to influence, drive continuous improvement, and support business objectives.
Willingness to travel as required.

Execute and oversee local PV processes in accordance with local, regional, and global regulatory requirements.
Manage adverse event (AE) reporting activities, including case intake, follow-up, translation, assessment support, and timely submissions.
Coordinate local PV agreements, due diligence activities, safety reporting obligations, and PV training initiatives.
Support audits, inspections, self-inspections, and CAPA management activities.
Develop, maintain, and implement local PV procedures, documentation, and compliance controls.
Ensure implementation and oversight of risk minimization measures and other local PV requirements.
Conduct literature surveillance and assess potential safety-related information as applicable.
Serve as a PV subject matter expert and provide guidance to internal stakeholders.
Collaborate with business functions, external partners, vendors, and health authorities on PV-related matters.
Support business continuity, quality improvement, and strategic PV initiatives.
May provide people leadership, mentoring, and oversight of assigned staff or contractors.
Participate in cross-functional projects and process improvement initiatives.
Act as the local PV expert and primary contact for Health Authorities.