Pharmacovigilance Associate
Job Summary The Pharmacovigilance Associate supports global pharmacovigilance (PV) operations by managing procedural documents and overseeing the maintenance of global and local Pharmacovigilance System Master Files (PSMFs). The position ensures compliance with regulatory requirements, drives document standardization, and collaborates cross-functionally to deliver high-quality, audit-ready documentation and processes.
Responsibilities
- Manage creation, review, revision, and control of PV procedural documents, SOPs, and policies.
- Lead document standardization efforts, ensuring alignment, consistency, and adherence to global documentation frameworks.
- Support end-to-end document change control processes and advise stakeholders on document strategy.
- Maintain Global and Local PSMFs, including data collection, quality control, formatting, publishing, and lifecycle management.
- Perform PSMF quality checks, consistency reviews, and ensure alignment with core PV strategies and regulatory requirements.
- Collaborate with cross-functional teams (e.g., PV, Quality, Regulatory) to gather inputs and resolve documentation issues.
- Support audits and inspections as a PSMF subject matter expert.
- Utilize systems such as Veeva QualityDocs to manage workflows and documentation.
- Identify risks, escalate issues, and contribute to continuous process improvement initiatives.
Qualifications
- Minimum 5+ years of pharmacovigilance experience in operational roles.
- At least 3 years of experience in PV quality management, document standards, and PSMF maintenance.
- Strong knowledge of global PV regulations and compliance requirements.
- Experience with document management systems, preferably Veeva QualityDocs.
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