Pharmacovigilance Services Specialist (Team Lead / Consultant)
Company: Accenture
Location: Bengaluru, Karnataka, India
Employment Type: Full-Time
Experience Required: 7 to 11 Years
Job ID: AIOC-S01619368
Industry: Pharmacovigilance | Drug Safety | Life Sciences
Job Overview
Accenture is seeking an experienced Pharmacovigilance Services Specialist to join its Life Sciences R&D division. This role is designed for senior pharmacovigilance professionals with strong expertise in drug safety surveillance, ICSR management, and global regulatory compliance, who can contribute both as a subject matter expert and a team lead within complex client engagements.
Key Responsibilities
Manage and oversee end-to-end pharmacovigilance operations, including case intake, processing, MedDRA coding, submissions, and follow-ups for ICSRs.
Monitor, evaluate, and assess the safety profile of pharmaceutical products in accordance with global regulatory standards.
Ensure compliance with ICH, FDA, EMA, and other global pharmacovigilance regulations and client-specific guidelines.
Perform detailed case analysis and resolution of moderately complex safety issues.
Support development and optimization of pharmacovigilance workflows, processes, and operating models.
Provide guidance, mentoring, and operational oversight to junior team members or small project teams.
Collaborate with internal stakeholders and client teams to ensure timely and high-quality safety deliverables.
Participate in audits, inspections, and regulatory readiness activities as required.
Adapt to rotational shift requirements based on global project needs.
Experience Required
7 to 11 years of relevant experience in Pharmacovigilance Operations or Drug Safety Surveillance.
Demonstrated hands-on expertise in ICSR processing, safety databases, MedDRA coding, and regulatory reporting.
Prior exposure to team leadership, consulting roles, or client-facing engagements is highly desirable.
Educational Qualifications
Bachelor of Pharmacy (B.Pharm)
Master of Pharmacy (M.Pharm)
MBBS
Key Skills and Competencies
Pharmacovigilance operations and drug safety surveillance
ICSR lifecycle management
MedDRA coding and case quality review
Global regulatory compliance (ICH, FDA, EMA)
Safety database management
Problem-solving and analytical skills
Stakeholder communication and collaboration
Team leadership and mentoring
Why Join Accenture
Accenture offers an opportunity to work at the forefront of global life sciences innovation, supporting leading biopharmaceutical organizations while advancing patient safety worldwide. You will be part of a collaborative, technology-driven environment that values expertise, continuous learning, and career growth.
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