Macleods Pharma is a globally recognized pharmaceutical company committed to delivering high-quality, affordable healthcare solutions. With a strong presence in over 50 countries, Macleods specializes in generics, biologics, and innovative therapeutics. The company fosters a dynamic work environment, encouraging professional growth and excellence in drug safety and regulatory compliance.
Job Description: Pharmacovigilance (Literature Surveillance)
The role involves Pharmacovigilance System Master File (PSMF) activities for the Europe region, ensuring compliance with GVP modules, MHRA UK guidelines, ICH-GCP, and local regulations.
Key Responsibilities:
✔ Drafting & Reviewing PSMF for Europe, UK, and ROW countries.
✔ Interdepartmental coordination for data collection, review, and tracking.
✔ Updating SmPC & PIL as per PRAC, CMDh, CHMP, and Signal requirements.
✔ Monitoring regulatory updates (EMA, MHRA, EC decisions, HMA) for safety-related changes.
✔ Comparing & reviewing SmPC/PIL regularly and ensuring compliance with SOPs.
✔ Resolving safety-related queries from vendors, LRPs, QPPV, and regulatory authorities.
✔ Maintaining safety variation tracker and updating SOPs as per guideline changes.
✔ Document management (PSMF, RSI, safety variation approvals, grant letters).
Required Skills & Qualifications:
- M.Pharma (Pharmacology)/B. Pharma with 2 -7 years of PV experience.
- Strong knowledge of GVP modules, MHRA UK guidelines, ICH-GCP, and EU regulations.
- Expertise in regulatory website navigation (EMA, MHRA, HMA).
- Excellent written & verbal communication and multitasking abilities.
How to Apply?
Interested candidates meeting the criteria can share their resume at:
📧 adityab@macleodspharma.com
Note: Freshers are requested not to apply. Only experienced professionals will be considered.