Job Description
Education : M Pharm in Pharmacology
Experience required : 6-8 years of experience in safety variations activity (experience related to SPC and PIL preparation (EU module 1) is preferable).
Job Descriptions:
1. To compile and review product information (SPC, PIL and Label) for safety variation (including PRAC, PSUSA, PSUFU, agency request etc.) and non-safety variation affecting the product information
2. To evaluate and review the approved PI documents to keep approved PI documents in-line with reference product to comply regulatory requirements.
3. To prepare and review submission of post-approval changes for RMP and PSUR submission.
4. To prepare and review responses to queries of the safety variations.
5. To prepare and publish eCTD variation document for safety variations and other request received from local affiliates.
6. To co-ordination with local affiliates, translators and artwork department for national text and mock-ups for timely submission of safet...
Experience required : 6-8 years of experience in safety variations activity (experience related to SPC and PIL preparation (EU module 1) is preferable).
Job Descriptions:
1. To compile and review product information (SPC, PIL and Label) for safety variation (including PRAC, PSUSA, PSUFU, agency request etc.) and non-safety variation affecting the product information
2. To evaluate and review the approved PI documents to keep approved PI documents in-line with reference product to comply regulatory requirements.
3. To prepare and review submission of post-approval changes for RMP and PSUR submission.
4. To prepare and review responses to queries of the safety variations.
5. To prepare and publish eCTD variation document for safety variations and other request received from local affiliates.
6. To co-ordination with local affiliates, translators and artwork department for national text and mock-ups for timely submission of safet...
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