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.
Robust 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
Perks:
Health insurance
Internet reimbursement
Paid time off
Provident Fund