Roles and Responsibilities :

- Monitor adverse events and serious adverse events reported in clinical trials.

- Collaborate with cross-functional teams to investigate cases, identify root causes, and implement corrective actions.

- Develop and maintain medical monitoring plans for clinical trial protocols, including risk assessments and mitigation strategies.

- Provide medical expertise on pharmacovigilance activities such as case processing, coding, and labelling.

- Ensure compliance with ICH guidelines related to GXP data management and pharmacovigilance.

- Prepare high-quality documents for regulatory submissions using excellent medical writing skills.

Job Requirements :

- Minimum 5 years of experience in the pharmaceutical industry with a focus on clinical trials,



medical affairs, or pharmacovigilance.

- Strong understanding of ICH guidelines related to GXP data management and pharmacovigilance.

- Excellent medical writing skills are required for preparing high-quality documents for regulatory submissions.

- Experience in signal detection, clinical trials, and medical monitoring is essential.

- Knowledge of pharmacovigilance activities, including case processing, coding, and labelling, is necessary.

- A solid educational background in a relevant field is preferred.

📌 lead medical monitor (Mumbai)
🏢 Wockhardt
📍 Mumbai