Urgent opening for Global Pharmacovigilance Agreement Specialist at Mumbai

Urgent opening for Global Pharmacovigilance Agreement Specialist at Mumbai

1 May, 2022

Urgent opening for GPV Agreement Specialist at Mumbai

Work Location : Mumbai

Exp Required : 2 to 5 Years

Domain: Life Sciences – Pharmacovigilance

Qualification: Life Sciences, Pharmacy, or equivalent degree

Eligibility:

Good working knowledge of global Pharmacovigilance regulations
Knowledge on Pharmacovigilance contractual agreements including global/local PV agreements or SDEAs.

Excellent written and verbal communication with internal and external customers.

Job Description:
1. To draft assigned PV Agreements/Safety Management Plans (new or revisions) and ensure that they are consistent with company requirements and aligned to the specific contract/study provisions.
2. To align and ensure that the newly drafted PVAs are in line with the older documents and meet company requirements.
3. To perform compliance monitoring of the effective PVAs.
4. To assist the PVA manager in managing and updating compliance metrics and documents/trackers.
5. To attend the PVA management team meetings and provide updates of any issues identified during day-to-day operations as applicable.
6. To attend periodic PVA status update meetings both internal & client, as applicable, to ensure project timelines are maintained.
7. To create minutes of PVA meetings, share for internal and external approvals as applicable and ensure archival on agreed portals.

Interested candidates share your CV on yashika@switchover.in

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