Executive – Regulatory Affairs
Sun Pharma
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Job Description
Location: Mumbai, Maharashtra, India
Job No.: AIOC-S01605263
Job Type: Full-Time
Experience: 0–2 years
Introduction
Accenture is a global professional services company providing services in digital, cloud, and security across more than 40 industries. The Pharmacovigilance Services Associate will be aligned with the Life Sciences R&D vertical, supporting pharmacovigilance operations, drug safety surveillance, and clinical trial data management. This role offers the opportunity to work with global biopharma clients, contributing to patient safety and regulatory compliance.
Role & Responsibilities
- Manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database.
- Perform written follow-up attempts for both Serious and Non-serious cases as per client guidelines and global regulatory requirements.
- Solve routine problems primarily through precedent and general guidelines.
- Interact mainly with team members and direct supervisors; support cross-functional teams when required.
- Follow detailed instructions for daily work and new assignments.
- Ensure accurate, timely, and compliant reporting of pharmacovigilance data.
- May work in rotational shifts as per operational requirements.
- Contribute as an individual team member with a focused scope of work while maintaining quality and compliance.
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Educational Qualification
Education:
- Bachelor of Pharmacy (B.Pharm) or Master of Pharmacy (M.Pharm).
Experience:
- 0–2 years of experience in drug safety, pharmacovigilance operations, or clinical research.
Skills & Competencies:
- Knowledge of pharmacovigilance and drug safety surveillance processes.
- Ability to follow instructions and maintain compliance with global regulatory requirements.
- Attention to detail, strong organizational skills, and ability to work under supervision.
- Effective written and verbal communication skills.
- Familiarity with MedDRA coding and safety database management is preferred.
Location
 Mumbai, Maharashtra, India
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