Nysa Biomed Pvt. Ltd. is looking for an experienced Pharmacovigilance Executive to manage pharmacovigilance activities and ensure compliance with regulatory requirements. The candidate will be responsible for adverse event monitoring, safety data management, medical review, and coordination with internal departments and regulatory authorities.

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.
- Strong analytical, communication, and problem-solving skills.
- Ability to work independently and meet regulatory timelines.

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

Advantages:

- Paid time off
- Provident Fund

Work Location: In person

📌 Pharmacovigilance (India)
🏢 NYSA BIOMED PRIVATE
📍 India