Job opening for Pharmacovigilance Manager
Role: PSMF Manager (Pharmacovigilance System Master File)
Preferred Educational Qualification for the role: College/University degree – A minimum of Bachelor’s Degree in life science (Bachelor of Science/Bachelor of Pharmacy/Master of Pharmacy/other Life Science graduates).
Preferred experience for the role: A minimum of 2-3 years of experience in Pharmacovigilance or allied fields. Broad understanding of relevant US, EU, and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments is desirable. Excellent communication skills, both written and verbal.
Reporting to (Role): Project Manager
Designee Role: Program Manager
Responsibilities PSMF Manager:
1. Communicate with stakeholders regarding upcoming Pharmacovigilance System Master File (PSMF) update and initiation
2. Initiate documents and route them through workflow steps in electronic document management system (EDMS) and assign appropriate stakeholders for PSMF modules and annexes
3. Communicate with stakeholders to resolve EDMS related queries and collaborate with Qualified Person for Pharmacovigilance/local safety officer on status update of the PSMF
4. Communicate with reviewers and schedule PSMF update review meetings
5. Update Annexes based on comments agreed in review meetings and support in PSMF quality assessment activity
6. Collaborate with reviewers to create the final version of the PSMF