Pharmacovigilance Associate (India)

Pharmacovigilance Associate (India)

23 Oct
|
vmysmartpros
|
India

23 Oct

vmysmartpros

India

Pharmacovigilance Associate

Company: vmysmartpros
Job Location: Remote (Work from home), India
Employment Type: Full time
Experience Required: 3+ years

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.

Apply To this Job

Company : Meet Life Sciences

Salary : Work from home .

📌 Pharmacovigilance Associate (India)
🏢 vmysmartpros
📍 India

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