Local PV Officer Consultant
Core
Ensuring local operating company safety activities comply with regulations and policies, managing pharmacovigilance case data, and reporting to health authorities.
Role type
Local Safety Officer Consultant (Pharmacovigilance)
Builds
Safety reporting and compliance processes for pharmaceutical and medical device clients
Domain
Healthcare / Pharmacovigilance
Deliverable
client delivery
Required skills
Case data management, regulatory timeline management, reconciliation, training oversight, document management, audit support, contract clause management, business continuity planning
Preferred skills
IT skills, knowledge of local pharmacovigilance requirements
Technologies
None explicitly stated
Responsibilities
Perform quality checks on 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, and internal stakeholders; submit safety reports (SAE, SUE, SUSARs, PSUR, RMP) to local health authorities; support local health authority inspections and audits; provide PV clauses for local agreements; implement local business continuity plans
Seniority
Mid-level, hands-on IC
