Job Description

Required Skills/Experience:

- Knowledge of pharmacovigilance and regulatory requirements of key regulatory authorities.
- Ability to work independently with minimal supervision.
- Solid communication and time management skills.
- Proven experience in team handling, including mentoring, performance management, and task delegation.

Key Responsibilities:

- Ensure the effective functioning of pharmacovigilance (PV) projects in compliance with client agreements and applicable regulations/guidelines.
- Take ownership of assigned projects and tasks, ensuring adherence to timelines and quality standards.
- Manage quality, compliance, and documentation across PV projects.
- Alert the functional head/designate regarding any personnel management concerns that may impact work quality or functioning.




- Collaborate continuously with internal and external stakeholders to ensure compliance with agreements, regulations, and guidance.
- Train and mentor personnel as needed.
- Identify and address training and development needs relevant to the function.
- Represent the department/function during audits and inspections.
- Author and review SOPs and other relevant documents as assigned by Management.
- Monitor and manage departmental workload, escalating concerns to the functional head/designate when necessary.
- Provide line management for assigned personnel as designated by Management.
- Perform other responsibilities as assigned by Management.

📌 Team Lead - CSPV (India)
🏢 Soterius
📍 India