Job Title: Pharmacovigilance (PV) Associate
Location: Mumbai, India (Work from Office)
Experience: 2–5 years in Pharmacovigilance
Notice Period: 0–30 days (Immediate joiners preferred)
Employment Type: Full-time
Contact Email: sandeep.biradar@cognizant.com
Job Summary
We are seeking Pharmacovigilance (PV) professionals with 2–5 years of experience to join our team in Mumbai. The ideal candidate will have hands-on experience in case processing, adverse event reporting, regulatory compliance, and safety database management. This is a work-from-office role, and immediate joiners will be given preference.
Key Responsibilities
Case Processing:
Perform triage, data entry, narrative writing, and medical coding for Individual Case Safety Reports (ICSRs).
Assess seriousness, expectedness, and causality of adverse drug reactions (ADRs).
Regulatory Compliance:
Ensure timely submission of ICSRs and aggregate reports to regulatory authorities as per global PV regulations.
Follow guidelines such as ICH-GCP, E2E, US FDA, EMA, and CDSCO requirements.
Signal Detection & Risk Management:
Assist in identifying potential safety signals and escalating critical cases.
Support risk management plans (RMPs) and periodic safety update reports (PSURs).
Quality & Compliance:
Maintain 100% compliance with SOPs, work instructions, and client-specific guidelines.
Participate in internal/external audits and inspections.
Collaboration & Communication:
Work closely with medical reviewers, regulatory teams, and cross-functional stakeholders.
Provide support in PV database maintenance and validation.
Qualifications & Requirements
Education:
Bachelor’s or Master’s degree in Pharmacy (B.Pharm/M.Pharm), Life Sciences, MBBS, BDS, BHMS, BAMS, or a related field.
Experience:
2–5 years of experience in Pharmacovigilance (PV) case processing, aggregate reporting, or medical review.
Technical Skills:
Proficiency in safety databases such as Argus, ARISg, or Veeva Vault.
Knowledge of MedDRA coding, WHO Drug Dictionary, and ICH E2B guidelines.
Familiarity with regulatory submission processes for ICSRs and PSURs.
Soft Skills:
Strong analytical and critical thinking abilities.
Excellent verbal and written communication skills.
Ability to work in a fast-paced, compliance-driven environment.
Additional Information
Location: Mumbai (Candidates must be currently residing in Mumbai).
Work Mode: On-site (Work from Office).
Joining: Immediate joiners preferred (0–30 days notice period).
How to Apply?
Interested candidates meeting the criteria can send their CVs to:
📧 sandeep.biradar@cognizant.com
⚠ Note: Please do not call regarding this role. Only shortlisted candidates will be contacted.
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