Opening Senior Clinical Research Associate Pharmacovigilance

UpgradeTalents; Bengaluru; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

UpgradeTalents is seeking a Senior Clinical Research Associate to join our Pharmacovigilance and Medical Safety team in Bangalore. The role focuses on patient safety, signal detection, and regulatory compliance across global studies.

You will review safety data, code ICSRs, support safety surveillance, and contribute to aggregate reports while mentoring junior reviewers and coordinating with client teams to ensure PV process excellence.

Qualifications

• 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 strong organizational, communication, and mentoring skills.

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.

Skills

Mentoring

Communication

Organizational skills

Cross-functional collaboration

Mentoring juniors

Education

MBBS

MD

Board certification

Tools

ARGUS

ArisG

MS Office

Job description

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.

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 strong organizational, communication, and mentoring skills.

Preferred Skills

• Sound medical and therapeutic knowledge.
• Ability to evaluate complex clinical safety data.
• High level of independence with a structured and detail-oriented approach.
• Proven ability to work in cross-functional teams across global setups.

Why Apply

This is a high-impact role for professionals passionate about drug safety, regulatory science, and global health. You will be working in a dynamic, team-oriented environment with opportunities for leadership, learning, and long-term career growth in clinical research.