Assistant Manager - Medical Safety Signal & Risk Management (Pharmacovigilance)

Designation : Asst. Manager

Department : Vigilance Competence Center Gurgaon,

Qualification : MBBS/MD with 2-3 years of experience in pharmacovigilance with expertise in medical review of aggregate reports (PSURs/PBRERs) (required), with experience in performing medical review of signal management and ICSRs (recommended).

Location : Gurgaon (Work from office is must with one-day flexi working option)

Job Responsibility

• Design, develop and maintain procedures for medical review activities (ICSRs, aggregate reports and signal management).
• Ensure high quality of ICSR, aggregate and signal management deliverables.
• Perform medical review of ICSRs, aggregate reports (PSURs/PBRERs), Risk Management plans, and signal reports.
• Participate in/organize review of safety label updates.
• Mentor and train medical reviewers.
• Provide product and therapeutic area trainings for the PV team.
• Provide cross-functional training on pharmacovigilance to medical writing and ICSR team members.

• Excellent interpersonal communication and writing skills with experience handling cross-functional projects
• Good conflict resolution skills
• Ability to work in a multi-cultural/global work environment
• Good mentoring skill