Area/Local Safety Officer Consultant
Core
Ensuring local operating company safety activities comply with regulations and policies, managing product vigilance agreements, and overseeing safety report submissions to health authorities.
Role type
Area/Local Safety Officer Consultant (Pharmacovigilance)
Builds
Safety and PV systems for pharmaceutical, biotechnology, medical device, and consumer health clients
Domain
Healthcare / Pharmacovigilance
Deliverable
client delivery
Required skills
Case data management, reconciliation, vigilance IT project management, regulatory monitoring, CAPA development, document management, audit support, contract management, business continuity planning
Preferred skills
Health care science professional training, strong IT skills, fluency in English and French
Technologies
None explicitly stated
Responsibilities
Perform quality checks of PV cases and ensure proper English translation; maintain local tracker of individual safety reports; oversee training of local employees and business partners; perform regulatory monitoring for impact on vigilance activities; reconcile with distributors, third parties, vendors, and internal stakeholders; perform reporting/submissions of safety reports (SAE, SUE, SUSARs, PSUR, RMP) to local health authorities; support notification of local health authorities regarding safety issues; maintain knowledge of local requirements for pharmacovigilance, cosmetic, and device vigilances; record non-conformances and develop CAPAs; support local health authority inspections and audits; provide PV clauses for local agreements; ensure implementation of local business continuity plans.
Seniority
Mid-level (2-4 years experience)
