Posted:6 hours ago|
Platform:
Work from Office
Full Time
Position: Sr. Research Scientist MSSRM
Department: Global Vigilance Centre – Gurgaon
Location: Gurgaon (Work From Office mandatory; 1-day flexi working option available)
Qualification Requirements
MBBS/MD with 0–3 years of experience in pharmacovigilance.
Mandatory: Expertise in medical review of aggregate reports (PSURs/PBRERs).
Preferred: Experience in medical review of signal management and ICSRs.
Key Responsibilities
Design, develop, and maintain procedures for medical review activities, including ICSR, aggregate reports, and signal management.
Ensure high-quality deliverables across ICSR, aggregate, and signal management outputs.
Perform medical review of ICSRs, aggregate reports (PSURs/PBRERs), Risk Management Plans, and signal reports.
Participate in and organize reviews of safety label updates.
Mentor and train medical reviewers.
Provide product and therapeutic area training for the PV team.
Deliver cross-functional pharmacovigilance training to medical writing and ICSR teams.
Behavioral Competencies
Strong interpersonal communication and writing skills.
Effective conflict resolution abilities.
Ability to work in a multicultural and global environment.
Good mentoring and coaching skills.
Fresenius Kabi
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