Pharmacovigilance PhysicianVenesco is seeking a Pharmacovigilance Physician to provide medical oversight and clinical expertise for all safety surveillance and pharmacovigilance activities. The physician is responsible for medical review of adverse events, causality assessments, safety signal evaluation, benefit-risk analyses, and regulatory safety reporting.Duties and ResponsibilitiesReview and assess serious adverse events.Perform causality and expectedness assessments.Lead benefit-risk evaluations and signal detection activities.Support expedited regulatory reporting requirements.Participate in DSMBs and safety review committees.Review protocols, Investigator Brochures, and informed consent forms.Contribute to IND safety reports, annual reports, DSURs, and safety communications.Provide medical safety consultation to project teams.Support safety surveillance and risk management planning.Participate in regulatory inspections and audits.Minimum QualificationsDoctor of Medicine (MD) degree.Current unrestricted U.S. medical license.Board Certified Physician.Minimum 10 years of clinical or pharmaceutical industry experience.Extensive drug safety and pharmacovigilance experience.Strong knowledge of FDA and ICH pharmacovigilance requirements.Venesco, LLC, is an equal opportunity and affirmative action employer. Venesco is committed to administering all employment and personnel actions on the basis of merit and free of discrimination based on race, ethnicity, religious affiliation, gender, gender identity or expression, sexual orientation, national origin, protected veteran status, or status as an individual with a disability. Consistent with this commitment, we are dedicated to the employment and advancement of qualified minorities, women, individuals with disabilities, protected veterans, persons of all ethnic backgrounds and religions according to their abilities.
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