Pharmacovigilance Physician

Consultant, PV Physician, Pharmaceuticals

Summary

Our growing, mid-sized pharmaceutical client has engaged GForce Life Sciences to provide a PV Physician Consultant who will serve as the product safety lead for clinical study safety.

Job Responsibilities:

• Serves as product safety lead for clinical study safety and spontaneous reporting of assigned products
• Maintain accurate and complete knowledge of assigned investigational and marketed products being monitored by the client, co-marketers, co-sponsors, and/ or affiliates
• Strategically discuss in cross-functional meetings for clinical development program phase 1,2 and 3 trials Support signal detection activities, literature review activities
• Support aggregate reports, PSUR, DSUR, RMPs, and Health Authority requests Represent safety lead in medical monitoring meetings, and data monitoring board meetings (DSMB) Represents CS&PV at interdepartmental team meetings
• Actively review and present data during safety governance meetings
• Represents CS&PV at meetings conducted with licensing partners, agents, contract research organizations, and clinical site investigators

Required Skills Include:

• Medical Degree (MD/MBBS/US license preferred but not required if the applicant has enough skills and experience)
• 3-5 years of PV and medical safety experience
• Medical review experience
• Aggregate reports such as PSUR, DSUR experience
• RMP authoring experience.
• Signaling review skills and experience
• Safety monitoring in clinical trials/ experience with presenting and discussing safety at Data monitoring board meetings

Term & Start

· 12-month contract, open to 12+ month extension

· 2 Video Interviews - Start 2-3 weeks from an offer

· Full time, 40 hours/week

· Remote –ability to work East coast hours

· Benefits available (Medical, Dental, Vision, 401k

· Hourly Rate Range - 68-72hr