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Pharmacovigilance (Pv) Associate

2-5 years
Not Disclosed
10 Feb. 24, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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.