Clinical Project Assistant
SanofiÂ
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Job Description
Full Time | Experience: 0-2 years
Location: Bengaluru, India
Job No.: AIOC-S01605309
Role & Responsibilities
Accenture is a global professional services company with leading capabilities in digital, cloud, and security. Our Life Sciences R&D vertical spans the entire life sciences enterprise—from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions.
As a Pharmacovigilance Services Associate, you will be part of a team providing pharmacovigilance and drug safety services to top biopharma companies. You will manage case processing, data entry, MedDRA coding, follow-ups, and regulatory submissions in compliance with global guidelines.
Role & Responsibilities
- Manage the Affiliate Mailbox and reconcile reports per process.
- Process both Serious and Non-serious ICSRs including case identification, data entry, coding, submission, and follow-ups.
- Follow standard operating procedures and global regulatory requirements (ICH, FDA, EMA).
- Solve routine problems largely through precedent and reference to guidelines.
- Interact within your team and direct supervisor for daily assignments.
- Make decisions impacting your own work as an individual contributor.
- Work in rotational shifts, if required.
- Maintain accuracy, attention to detail, and quality in all deliverables.
Educational Qualification
- Bachelor of Pharmacy (B.Pharm) or Master of Pharmacy (M.Pharm) – Mandatory
- 1–3 years of experience in drug safety or pharmacovigilance preferred.Knowledge of ICSR processing, MedDRA coding, and regulatory submissions.
- Familiarity with pharmacovigilance databases and global safety guidelines.
- Strong analytical, problem-solving, and organizational skills.
- Effective written and verbal communication skills.
- Ability to work independently and in a team environment.
Location
Bengaluru
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