Piramal Critical Care is a leading global healthcare company specializing in critical care and anesthesia products. With a strong commitment to patient safety and innovation, Piramal Critical Care operates in over 100 countries, delivering high-quality pharmaceutical solutions. The company is known for its robust pharmacovigilance system and compliance with global regulatory standards.
Job Description: Executive – Pharmacovigilance
The Executive – Pharmacovigilance will be responsible for end-to-end case management, including ICSR (Individual Case Safety Report) processing, literature screening, and aggregate safety report authoring. This role ensures compliance with global pharmacovigilance regulations and timely reporting to regulatory authorities.
Key Responsibilities:
✔ Case Management:
- Receiving, tracking, and processing ICSRs from various sources.
- Downloading cases from regulatory authority websites and entering them into the safety database.
- Conducting peer reviews and submitting reports within stipulated timelines.
✔ Mailbox Management:
- Monitoring and reconciling incoming ICSRs.
- Ensuring timely follow-up for additional case information.
✔ Literature Screening:
- Performing regular literature searches for adverse event reports related to company products.
✔ Aggregate Report Preparation:
- Drafting and reviewing Periodic Adverse Drug Experience Reports (PADERs) and Periodic Benefit-Risk Evaluation Reports (PBRERs).
✔ Compliance & Audits:
- Maintaining safety logs and files.
- Assisting in internal/external audits and regulatory inspections.
✔ Stakeholder Coordination:
- Collaborating with Quality, Regulatory Affairs, and Supply Chain teams.
- Responding to regulatory queries related to drug safety.
Eligibility Criteria
Essential Qualification:
- B.Pharm / M.Pharm (Freshers may apply)
Preferred Experience:
- 0-1 years in Pharmacovigilance with exposure to ICSR processing, literature screening, and aggregate report writing.
Key Competencies:
✅ Strong communication & interpersonal skills
✅ Ability to manage multiple tasks efficiently
✅ Proficiency in Microsoft Office (Word, Excel, PowerPoint)
✅ Knowledge of global pharmacovigilance regulations (US FDA, EMA, etc.)
How to Apply?
