Pharmacovigilance Associate

Location: Kodambakkam / Gummidipoondi

Department: Pharmacovigilance

Position: Pharmacovigilance (PV) Associate

Job Type: Full-time

Role Overview :

The Pharmacovigilance (PV) Associate is responsible for the timely and accurate processing of adverse event reports, ensuring compliance with global and local regulatory requirements for drug safety.

Key Job Responsibilities

1. Case Management & Processing

• Receive and Triage:

  Intake and prioritize all incoming adverse event (AE) reports from various sources (e.g., spontaneous reports, literature, clinical trials, and regulatory authorities).

• Data Entry:

  Perform detailed and accurate data entry of AE reports ensuring complete case documentation.

• Case Narrative:

  Write clear, concise, and medically accurate

  case narratives

  that summarize.

• Follow-up:

  Initiate and manage follow-up queries with reporters (HCPs, patients) to obtain missing or clarifying information necessary for case completion.

2. Regulatory Compliance & Reporting

• Submission Timeliness:

  Ensure all expedited (e.g., 7-day, 15-day) and aggregate safety reports are processed and prepared for submission according to global and local regulatory timelines.
• Perform thorough quality checks on processed cases to ensure data integrity, accuracy, and adherence to company SOPs and regulatory standards.

• Reconciliation:

  Assist in the reconciliation of safety data with other departments (e.g., Quality Assurance) to ensure all adverse event reports have been captured.

3. Documentation & System Maintenance

• SOP Preparation:

  Follow

  Standard Operating Procedures (SOPs)

  and work instructions.

• Documentation:

  Maintain comprehensive and organized documentation for all case processing activities, including source documents and follow-up attempts.

Required Qualifications and Skills

• Education:

  A Bachelor's degree in a life science, pharmacy (B. Pharm/M. Pharm), nursing (BSc/MSc), or other health-related field is required.

• Experience:

  Fresher or +1 year of experience in Pharmacovigilance/Drug Safety, Clinical Research, or a related regulatory environment is preferred.

• Knowledge:

  Foundational knowledge of global PV regulations (e.g., ICH guidelines, FDA, EMA).

• Core Competencies:

  Strong attention to detail, excellent organizational and communication (written and verbal) skills, and the ability to work effectively.

GreenSignal Bio Pharma Private Limited