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Pharmacovigilance Services Specialist

Accenture
Accenture
7-11 years
preferred by company
Chennai, India
1 May 13, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding

Job Title: Pharmacovigilance Services Specialist

Location: Chennai, Tamil Nadu, India
Job Type: Full-Time
Experience Required: 7–11 Years (Freshers are not eligible)
Industry: Pharmacovigilance / Drug Safety / Medical Safety / Pharmaceuticals / Life Sciences / Healthcare Operations
Department: Pharmacovigilance Operations / Drug Safety Surveillance / Medical Review

About the Role
We are seeking an experienced and medically qualified Pharmacovigilance Services Specialist to lead advanced drug safety surveillance, medical review, pharmacovigilance compliance, and adverse event assessment within a global pharmacovigilance operations environment. This senior-level opportunity is ideal for professionals with expertise in ICSR medical review, adverse event causality assessment, MedDRA coding oversight, pharmacovigilance compliance, and global drug safety operations.

The ideal candidate will be responsible for conducting medically sound safety case reviews, ensuring regulatory compliance, supporting pharmacovigilance process governance, mentoring operational teams, and driving quality excellence across global drug safety workflows.

This role is highly suited for experienced medical professionals seeking leadership growth in pharmacovigilance and medical safety operations.

Key Responsibilities

Medical Review & Drug Safety Assessment

  • Perform end-to-end medical review of Individual Case Safety Reports (ICSRs) within defined turnaround timelines and regulatory deadlines.
  • Conduct medically accurate assessment of:
    • Seriousness classification
    • Causality assessment
    • Labeling evaluation
    • Adverse event clinical review
    • Medical consistency validation
  • Ensure all case evaluations align with client SOPs, pharmacovigilance standards, and global regulatory requirements.

ICSR Processing Oversight & Safety Case Governance

  • Prioritize medical review activities based on regulatory due dates, SLA commitments, business priorities, and pharmacovigilance workflows.
  • Review source documents, narratives, and case information to ensure medical completeness and clinical accuracy.
  • Validate case consistency and update relevant safety database fields when required.
  • Perform self-quality review and E2B validation checks before routing cases to downstream workflows.

MedDRA Coding & Safety Data Quality Assurance

  • Verify appropriate selection and oversight of MedDRA coding, adverse event classification, medical terminology interpretation, and safety data quality.
  • Ensure alignment with applicable coding dictionaries including WHO-Drug and MedDRA standards.
  • Maintain high standards of pharmacovigilance data integrity and coding accuracy.

Medical Writing & Safety Documentation

  • Draft medically sound company causality comments, pharmacovigilance documentation, case narratives, agendas, meeting minutes, and safety documentation.
  • Ensure scientific accuracy, clarity, and compliance in safety documentation deliverables.
  • Support documentation archiving and audit-ready pharmacovigilance record maintenance.

Safety Queries, Escalations & Cross-Functional Support

  • Address medical assessment queries raised by case processors, literature reviewers, quality teams, triage associates, clients, license partners, and regulatory stakeholders.
  • Determine the need for follow-up information, clarification requests, and additional medical documentation.
  • Escalate complex safety concerns to Global Safety Physicians when required.

Pharmacovigilance Compliance & Process Governance

  • Ensure adherence to pharmacovigilance SOPs, regulatory compliance frameworks, safety governance requirements, and quality expectations.
  • Support oversight of pharmacovigilance process maintenance, compliance monitoring, and operational risk management.
  • Stay current with evolving client procedures, regulatory expectations, and global pharmacovigilance standards.

Training, Leadership & Team Development

  • Lead training initiatives for internal and cross-functional teams on pharmacovigilance processes, adverse event reporting, and safety review practices.
  • Provide mentorship, operational guidance, and case discussion leadership to drug safety teams.
  • Support transition activities, workflow improvements, and operational knowledge development.

Operational Excellence & Continuous Improvement

  • Contribute to process optimization, quality enhancement, and operational excellence initiatives in pharmacovigilance operations.
  • Support cross-functional transitions and flexible role movement based on business requirements.