Pharmacovigilance Services Specialist (Medical Reviewer)
Role Level: Team Lead / Consultant
Company: Accenture
Job ID: AIOC-S01621378
Location: Chennai, India
Employment Type: Full-Time
Experience Required: 7–11 Years
Education Requirement: MBBS / MD
Job Overview
Accenture is hiring an experienced Pharmacovigilance Services Specialist to lead and perform medical review and safety assessment activities across global pharmacovigilance programs. This role is designed for senior medical professionals with extensive experience in drug safety surveillance, ICSR medical review, and regulatory compliance within global PV operations.
The position plays a critical role in ensuring accurate medical assessment, regulatory adherence, and high-quality safety decision-making in line with client SOPs and international guidelines.
Key Responsibilities
Medical Review & Case Evaluation
Perform medical review of Individual Case Safety Reports (ICSRs) in compliance with global regulatory timelines and client SLAs
Assess and confirm seriousness, causality, expectedness, and labeling of adverse events
Validate MedDRA coding, adverse event selection, and narrative accuracy
Write and document company causality assessments in the global safety database
Pharmacovigilance Operations & Compliance
Ensure all safety activities comply with global regulatory requirements, client SOPs, and internal quality standards
Conduct E2B validation checks and self-reviews before case progression
Identify missing or unclear information and initiate follow-up activities as per SOPs
Support responses to queries from regulatory authorities, clients, and license partners
Leadership & Stakeholder Collaboration
Provide medical guidance to case processing associates, literature reviewers, triage, and quality teams
Lead internal and cross-functional training on safety assessment and adverse event reporting
Participate in client case discussions, offering expert medical input
Collaborate with global safety physicians for complex case evaluations when required
Process Improvement & Knowledge Management
Contribute to process improvement initiatives and pharmacovigilance compliance oversight
Support activity transitions, knowledge transfers, and operational readiness
Assist in drafting pharmacovigilance meeting agendas, minutes, and documentation
Maintain accurate archiving and audit-ready pharmacovigilance records
Education & Experience Requirements
Education:
MBBS or MD (Mandatory)
Experience:
7–11 years of hands-on experience in Pharmacovigilance / Drug Safety
Strong background in medical review of ICSRs within global PV environments
Prior experience in team leadership, mentoring, or consultant-level responsibilities preferred
Required Skills & Competencies
Strong knowledge of medical terminology and safety dictionaries (MedDRA, WHO-Drug)
Proven expertise in ICSR medical assessment, causality evaluation, and regulatory reporting
Experience working with global safety databases
Excellent medical writing and documentation skills
Strong command of English language (reading, writing, listening, speaking)
Proficiency in MS Office tools
Ability to work independently in a high-compliance, deadline-driven environment
Performance Expectations
Accurate and timely completion of medical reviews in line with regulatory timelines
High-quality documentation with zero critical compliance deviations
Active contribution to training, mentoring, and process excellence
Continuous upskilling through SOP updates and mandatory PV trainings
About Accenture
Accenture is a global professional services leader with expertise spanning digital, cloud, security, and life sciences operations. With a workforce of over 699,000 professionals across 120+ countries, Accenture partners with leading pharmaceutical and biotech organizations to deliver end-to-end pharmacovigilance, regulatory, and clinical solutions.
Apply now on ThePharmaDaily.com to advance your career in global pharmacovigilance leadership and medical safety operations.
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