Global Risk Management, PV Scientist
ProClinical, in support of our client, are seeking an individual to fill the role of Global Risk Management and Safety Surveillance (PV Drug Safety) Scientist, based in Philadelphia, PA. The successful candidate will collaborate with the PV/Drug Safety Physician to characterize the evolving clinical and safety profiles for investigational drugs and/or products.
- Support PV Drug Safety Physician and coordinate Safety Governance Team meetings.
- Formulate clinical trial and risk management safety strategies.
- Perform drug signal management activities.
- Prepare RMPs and ensure their execution throughout the lifecycle of a medicinal product.
- Author first-round drafts of all ad hoc and scheduled safety evaluations.
- Review periodic literature for new and important information regarding
- Drive preparation of DSURs for clinical trial programs, and PBRERs for marketed products.
- Participate in the review of safety summaries, clinical overviews, and other registration documents.
- Evaluate data and compile the RSI for marketed products.
- Participate in internal safety process improvements and updates.
- Contribute to preparedness for regulatory authority inspection and internal audits of PV; contribute to the development and implementation of any preventative and/or corrective action plans as they pertain to specific deficiencies of policy, procedure, or practice in PV Drug Safety.
- Champion risk management safety strategy to internal and external stakeholders.
Skills And Qualifications
- Nursing, PhD or PharmD degree and experience analyzing case reports.
- Experience incorporating safety findings into reference safety information.
- Experience in pharmacovigilance relating to oncologic or inflammatory diseases, or relating to clinical support of oncology, immunomodulatory, or other related products preferred
- Experience in pharmaceutical industry activities involving health authorities outside the United States preferred.
- Fluency in written and spoken English.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Tong at (+1) 646-878-6308 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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