Assistant Mgr / Dy. Mgr- Medical Writing- Pharmacovigilance
4 - 7 YearsAhmedabad Openings: 1
Job Description
1. Act as a Subject matter expert (SME) and Mentor for Aggregate Report Team
2. Lead/co-lead cross functional expert teams to fulfill Periodic Safety Report accountability (Clinical, Marketing).
3. Prepare and maintain aggregate reports schedule.
4. Preparation, review and submission of Periodic Safety Update Reports (PSURs)/Periodic Adverse Drug Experience Reports (PADERs)/Risk Management Plan (RMP)/other periodic report.
5. Responding regulatory assessment reports on RMPs and PSURs.
6. Performing signal management activities.
7. Ensure compliance (quality, procedures, regulations, timeliness, consistency) of aggregate reports
8. Assist in preparation/revision of SOP, Work instructions, templates and guidance training documents.
9. Support Health Authorities inspections and audits, and development of Corrective & Preventative Actions (CAPA) to address safety findings.
10. Handling queries of local affiliates/regulatory agency.
Company Profile
2. Lead/co-lead cross functional expert teams to fulfill Periodic Safety Report accountability (Clinical, Marketing).
3. Prepare and maintain aggregate reports schedule.
4. Preparation, review and submission of Periodic Safety Update Reports (PSURs)/Periodic Adverse Drug Experience Reports (PADERs)/Risk Management Plan (RMP)/other periodic report.
5. Responding regulatory assessment reports on RMPs and PSURs.
6. Performing signal management activities.
7. Ensure compliance (quality, procedures, regulations, timeliness, consistency) of aggregate reports
8. Assist in preparation/revision of SOP, Work instructions, templates and guidance training documents.
9. Support Health Authorities inspections and audits, and development of Corrective & Preventative Actions (CAPA) to address safety findings.
10. Handling queries of local affiliates/regulatory agency.
Company Profile
Zydus Cadila is an innovative global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare products. The groups operations range from API to formulations, animal health products and cosmeceuticals. Headquartered in the city of Ahmedabad in India, the group has global operations in four continents spread across USA, Europe, Brazil, South Africa and other emerging markets.
In its mission to create healthier communities globally, Zydus Cadila delivers wide ranging healthcare solutions and value to its customers. With a strong dedicated employees worldwide, a world-class research and development center dedicated to discovery research and eight state-of-the-art manufacturing plants, the group is dedicated to improving peoples lives.
In its mission to create healthier communities globally, Zydus Cadila delivers wide ranging healthcare solutions and value to its customers. With a strong dedicated employees worldwide, a world-class research and development center dedicated to discovery research and eight state-of-the-art manufacturing plants, the group is dedicated to improving peoples lives.
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