Drug Safety Associate

Role & responsibilities

As a Drug Safety Associate / Pharmacovigilance Associate, you will be involved in adverse event case processing, safety data entry, and regulatorycompliant reporting under the guidance of senior safety specialists.medipharmsolutions+2

Key Responsibilities:

• Receive, review and process Individual Case Safety Reports (ICSRs) from clinical trials and postmarketing sources.biotecnika+2
• Perform data entry of adverse events into pharmacovigilance / safety databases with high accuracy and timelines.himalayas+2
• Perform MedDRA coding of adverse events, drugs and medical history (training will be provided).cliniminds+2
• Assist in the preparation of case narratives, followup queries and basic safety reports for regulatory submission.biotecnika+1
• Support literature surveillance and safety information tracking as per project requirements.bcri+1
• Maintain documentation, follow SOPs / work instructions and ensure compliance with global drug safety regulations.iicrm+2
• Work closely with senior Drug Safety / PV team members on quality checks and continuous improvement