Company: Macleods Pharma Ltd
Required experienced PSMF profile in Pharma Covigilance department of RND Andheri, Mumbai.
Experience: 3 to 7 years
PSMF activity for Europe region:
- To draft and review PSMF Europe, UK , ROW country.
- To request data from stakeholder and review data received from stakeholder, (interdepartmental communication require) and maintain tracker PSMF.
- To update SmPC and PIL as per requirements (PRAC, CMDh, CHMP, Signal etc.) .Able to search regulatory website for any new updates (eg EMA, MHRA, EC decision, HMA).
- Interdepartmental Communication with RA department for innovator, common text, any query.
- Review and monitor regulatory updates for safety-related changes via website review.
- To compare & review the SmPC/PIL on a regular basis as per SOP and identify the changes to be filed.
- To resolve the safety-related queries received from vendors, LRPs, QPPV, and Regulatory Authority.
- To maintain and update the safety variation tracker as per SOP
- To update the SOP as and when require (eg guideline updates)
- Manage and archive all the documents email related to PSMF, the RSI, safety variation approval documents, grant letters.
- Good Knowledge of GVP modules, MHRA UK guideline, ICH GCP guidelines, country specific local regulations require.
- Good written and verbal communication, multitasking require.
Education: M. Pharma (Pharmacology)
Mail me - adityab@macleodspharma.com
Note : Fresher do not apply for this position. Experienced candidate please mention PSMF in subject.
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