? Location: Bangalore, India

? Department: Pharmacovigilance and Safety

? Employment Type: Full-Time

? Level: Associate

? About the Role

We are currently seeking a Senior Clinical Research Associate to join our Pharmacovigilance and Medical Safety team. This role is ideal for experienced medical professionals looking to play a key part in patient safety, signal detection, and regulatory compliance across global studies.

? Key Responsibilities

Conduct medical review and assessment of safety data from clinical trials, spontaneous reports, and solicited reports.
Determine regulatory reportability, seriousness, and relatedness of adverse events (AEs) and adverse drug reactions (ADRs).
Perform MedDRA coding and narrative review of individual case safety reports (ICSRs).
Support safety surveillance strategies and signal detection activities.
Participate in the preparation of aggregate reports such as PSURs, DSURs, RMPs, and signal reports.
Contribute to risk management planning and safety strategy across multiple therapeutic areas.




Lead/support post-marketing safety studies and resolution of site-level issues.
Mentor junior medical reviewers and serve as subject matter expert in PV processes.
Liaise with client medical and regulatory teams to ensure clarity and compliance.

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✅ Candidate Requirements

Education: MBBS or MD; board certification or higher medical qualification preferred.
Experience: Prior experience in pharmacovigilance, medical review, or clinical safety is essential.
Strong understanding of GCP, pharmacovigilance regulations, and regulatory obligations.
Familiarity with safety databases (e.g., ARGUS, ArisG) and proficiency in MS Office.
Excellent command of English; other languages are a plus.
Must possess solid organizational, communication, and mentoring skills.

? Preferred Skills

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Sound medical and therapeutic knowledge.
Ability to evaluate complex clinical safety data.
High level of independence with a structured a

📌 ? Job Opening: Senior Clinical Research Associate – Pharmacovigilance (Bengaluru)
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📍 Bengaluru