Associate Medical Safety Director

Job highlights

• Maintain awareness of medical-safety-regulatory industry developments. Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users

• Perform medical review and clarification of trial-related Adverse Events (AEs) and post-marketing adverse drug reactions (ADRs).

• Compose, edit, and medically review Analyses of Similar Events (AOSE) for expedited cases.

• Serve as an internal consultant to pharmacovigilance case processing teams on projects being supported.

• Provide aggregate reviews of safety information, including clinical data, to maintain oversight of a product's safety profile.

• Represent safety and clinical data review findings during client meetings.

• Review and sign off on both the Project Safety Plan and the Medical Monitoring Plan per medical safety scope agreed in contract.

• Act as Global Safety Physician or Assistant or Back-up on projects as assigned.

• Attend project meetings, medical safety team meetings, and client meetings as requested.

• Ensure coverage for all medical safety deliverables within regulatory or contracted timelines.

• Provide medical escalation support for medical information projects and EU Qualified Persons for Pharmacovigilance projects.

• Maintain awareness of medical-safety-regulatory industry developments.

Disclaimer: This job description has been sourced from a public domain and may have been modified by Naukri.com to improve clarity for our users. We encourage job seekers to verify all details directly with the employer via their official channels before applying.