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
Seniority level
Associate
Employment type
Contract
Job function
Health Care Provider, Science, and Strategy/Planning
Industries
Hospitals and Health Care and Pharmaceutical Manufacturing
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