Drug safety associate trainee (sitero)

Roles and Responsibilities

A Drug Safety Associate Trainee is an entry-level role in Pharmacovigilance (PV) focused on learning how to monitor, assess, and report adverse drug reactions (ADRs) to ensure patient safety and regulatory compliance.

What a Drug Safety Associate Trainee does

• Learn ICSR (Individual Case Safety Report) processing

• Perform case intake from sources like emails, call centers, literature, and clinical trials

• Enter and validate data in safety databases (Argus, ArisG, VigiFlow, etc.)

• Assist in medical coding (MedDRA, WHO-DD)

• Draft basic case narratives under supervision

• Follow ICH-GCP, ICH-E2 guidelines, FDA, EMA regulations

• Support quality checks and compliance activities

Eligibility

• Pharm.D / B.Pharm / M.Pharm / Life Sciences graduates

• Freshers or candidates with 0–1 year experience

• Pharmacovigilance certification is an added advantage

Key skills required

• Basic understanding of pharmacology & ADRs

• Knowledge of medical terminology

• Attention to detail & documentation skills

• Good written and verbal English communication

• Willingness to work in US/EU shifts (if required)

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