Key Responsibilities
- Collect, review, and process adverse event (AE), serious adverse event (SAE), and product quality complaint reports.
- Perform case processing, medical coding, causality assessment, and data entry.
- Prepare and submit Individual Case Safety Reports (ICSRs) within regulatory timelines.
- Prepare Periodic Safety Update Reports (PSURs), PADERs, and other pharmacovigilance reports as required.
- Maintain pharmacovigilance documentation and ensure compliance with SOPs, GVP guidelines, and regulatory requirements.
- Coordinate with Regulatory Affairs, Quality Assurance, Medical Affairs, Production, and Product Development teams.
- Monitor literature for safety-related information and perform literature screening.
- Support signal detection, risk management activities, and benefit-risk evaluation.
- Participate in internal and external audits and regulatory inspections.
- Prepare and revise pharmacovigilance SOPs, work instructions, and training documents.




- Ensure timely reporting of safety information to regulatory authorities and business partners.

Eligibility
- Qualification: B.Pharm / M.Pharm / Pharm.D / Life Sciences
- Experience: 3-5 years in Pharmacovigilance
- Experience in case processing and regulatory safety reporting is preferred.

Required Skills:
- Strong knowledge of Pharmacovigilance principles and GVP guidelines.
- Knowledge of ICH, CDSCO, and global pharmacovigilance regulations.
- Experience in adverse event case processing and medical coding.
- Good documentation and report writing skills.
- Proficiency in MS Office.
- Solid analytical, communication, and problem-solving skills.
- Ability to work independently and meet regulatory timelines.

Pay: ₹20,000.00 - ₹41,200.00 per month

Benefits:
- Paid time off
- Provident Fund

Work Location: In person

📌 Pharmacovigilance (Maharashtra)
🏢 NYSA BIOMED PRIVATE
📍 Maharashtra