Description
Role Overview
Purpose of Pharmacovigilance Associate role is to monitor and manage the safety aspects of clinical studies/ post marketing surveillance including but not limited to monitoring safety mailbox, preparation of safety management plan, setting up safety database for studies, processing & submission of ICSRs (SAE/SUSAR/AEs) in accordance with ICH-GCP, SOPs and applicable regulatory requirements/ ensure compliance with regulations.
Qualifications & Experience:
State the education qualifications required along with the desired experience level. Mention specific skills and certifications which the candidate should have to apply for the role.
Education
- Registered nurse/pharmacist or with health/biomedical degree or other related scientific degree/qualification is required.
- Postgraduate qualifications or certification in clinical trials will be an advantage.

Knowledge, Skills, and Abilities (Pharmacovigilance Associate)
- Knowledge of clinical trials and pharmacovigilance requirements.



Knowledge/experience in international drug safety-regulatory reporting obligations and compliance.
- Experience in coding medical terminologies, case processing, safety report submission is preferred.
- Thorough knowledge of medical terminology and ability to summarise medical information is required.
- Solid computer proficiency and ability to work in specific databases is required/preferred.
- Ability to follow guidelines and procedural documents is required. Experience of working with SOPs etc. is required.
- Fluent in both written and oral English.
- Good interpersonal skill to professionally communicate with all levels of the organizations.
- Good time management & multi-task capability.

Experiences
- 2 years to 4 years of pharmaceutical/CRO experience with focus on safety related areas in clinical trial is required.

Major Responsibilities:
Describe the tasks, duties, and responsibilities the employee who is working on this role is supposed to carry out. L

📌 Drug Safety Associate (India)
🏢 Novotech
📍 India