Qualification: Life Sciences Pharmacy or equivalent degree Work Location: Mumbai Preferred Experience: A minimum of Bachelors Degree in life science (Bachelor of Science/Bachelor of Pharmacy/Master of Pharmacy/other Life Science graduates) with a minimum 3-6 years of experience in Pharmacovigilance
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:
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.
To align and ensure that the newly drafted PVAs are in line with the older documents and meet company requirements.
To perform compliance monitoring of the effective PVAs.
To assist the PVA manager in managing and updating compliance metrics and documents/trackers.
To attend the PVA management team meetings and provide updates of any issues identified during day-to-day operations as applicable.
To attend periodic PVA status update meetings both internal & client as applicable to ensure project timelines are maintained.
To create minutes of PVA meetings share for internal and external approvals as applicable and ensure archival on agreed portals.
Employement Category:
Employement Type: Full timeIndustry: PharmaceuticalFunctional Area: PharmaceuticalRole Category: Pharmaceutical Research ScientistRole/Responsibilies: GPV Agreement Specialist