Macleods Pharmaceuticals Ltd is a leading Indian pharmaceutical company with a strong global presence. Known for its high-quality generic medicines, Macleods specializes in therapeutic areas such as anti-infectives, cardiovascular, and diabetes. The company is committed to patient safety and regulatory compliance, making Pharmacovigilance a critical function.
Job Description: ICSR Submission Expert
Key Responsibilities:
✔ Regulatory Submissions: Submit ICSR reports to global health authorities (EMA, MHRA, USFDA, India, and ROW countries).
✔ Case Validation: Ensure accurate ARGUS field checks (country of incidence, report type, expectedness, listedness).
✔ Regulatory Compliance: Identify reportable cases based on PV agreements and regulatory requirements.
✔ Submission Formats: Determine report types (E2B/CIOMS) and ensure timely submissions via Global PV mailbox.
✔ Query Resolution: Address internal and external queries related to ICSR submissions.
✔ Reconciliation: Perform monthly/quarterly report reconciliations.
✔ E2B Monitoring: Track and manage E2B submissions for ICSRs.
✔ Regulatory Coordination: Liaise with health authorities for submission-related activities.
Required Skills & Qualifications:
- Education: B.Pharm / M.Pharm / PharmD
- Experience: 2-4 years in Pharmacovigilance (ICSR submissions preferred).
- Technical Knowledge:
- Global PV regulations (EMA, FDA, MHRA, etc.)
- PV safety databases (ARGUS preferred)
- MedDRA coding and ICSR evaluation
- Soft Skills: Strong communication, attention to detail, problem-solving.
How to Apply?
Interested candidates with 2-4 years of Pharmacovigilance experience can send their updated resume to:
📧 Email: adityab@macleodspharma.com
Note: Freshers are requested not to apply. Only experienced candidates will be considered.
