Key Responsibilities:
- Case Management:
- Receive, document, and assess adverse event reports from various sources, including healthcare professionals, consumers, and regulatory authorities.
- Ensure accurate and timely data entry of adverse event information into the safety database.
- Conduct thorough case investigations and follow-up activities to obtain missing information.
- Signal Detection and Evaluation:
- Assist in the identification of potential safety signals through the analysis of aggregated safety data.
- Contribute to the evaluation of safety signals by reviewing relevant literature and data.
- Regulatory Compliance:
- Stay abreast of relevant pharmacovigilance regulations and guidelines.
- Assist in the preparation and submission of periodic safety reports to regulatory authorities.
- Collaboration and Communication:
- Collaborate with cross-functional teams, including Clinical Development, Regulatory Affairs, and Medical Affairs.
- Communicate effectively with internal and external stakeholders regarding safety-related issues.
- Quality Assurance:
- Participate in internal and external audits related to pharmacovigilance activities.
- Ensure compliance with internal Standard Operating Procedures (SOPs) and industry best practices.
Qualifications:
- Bachelor's degree in pharmacy, life sciences, nursing, or a related field.
- Strong attention to detail and excellent organizational skills.
- Effective communication and interpersonal skills.
- Ability to work independently and collaboratively in a team environment.
Job Types: Full time, Permanent, Fresher
Salary: ₹250,000.00 - ₹350,000.00 per year
Benefits:
- Health insurance
- Internet reimbursement
- Paid time off
- Provident Fund