Company: Macleods Pharmaceuticals Ltd.
Department: Pharmacovigilance (ICSR Profile)
Location: Andheri, Mumbai
Number of Positions: 01Experience
Required: 2 – 4 years
Employment Type: Full-Time
📝 Job Responsibilities:
- Submission of ICSR reports to regulatory bodies such as EMA, MHRA, USFDA, CDSCO (India), and RoW countries.
- Validate ARGUS fields influencing case submission (e.g. country of incidence, report type).
- Perform expectedness and listedness checks.
- Identify regulatory authorities, local operating companies, and license partners for reporting based on case specifics and PV agreements.
- Determine the report format (E2B or CIOMS) and submission timelines per applicable regulations.
- Submit reports manually via E2B or CIOMS through the global PV mailbox.
- Respond to regulatory queries on product safety issues for marketed products.
- Detect inconsistencies in ARGUS reports and coordinate changes for accurate reporting.
- Address internal and external queries related to case submissions.
- Conduct periodic reconciliation of reports (monthly/quarterly).
- Maintain and monitor submission-related reporting rules.
- Coordinate with regulatory authorities as needed for submission activities.
🎓 Minimum Qualification & Skills:
- Educational Background: B.Pharm / M.Pharm / Pharm.D
- Experience: 2–4 years in the Pharmacovigilance domain (ICSR processing and submission)
- Key Skills:
- Strong verbal and written communication
- Knowledge of global PV regulations and PV databases
- Familiarity with ARGUS safety database and MedDRA coding
- Competence in evaluating ICSR seriousness, relatedness, expectedness
- Experience in handling medical device malfunction reports (preferred)
📧 Application Process:
Interested and eligible candidates may send their updated CVs to:
👉 adityab@macleodspharma.com
Subject Line: Application for ICSR Submission Expert – Pharmacovigilance Department
You can share your article for Publication
For More Join our Whatsapp Group
https://chat.whatsapp.com/BeuLhn7wpsu9M8hdvzoUIX
Note:
Candidates who have applied for any of the above positions can avail free interview preparation support from our expert team.
You can share your article for Publication