Sr. Medical Dir, GRMSS
ProClinical, in support of our client, are seeking a talented individual to fill the role of Senior Medical Director, based in Philadelphia, PA. The successful candidate will be responsible for developing and ensuring execution of all patient safety risk management activities for relevant marketed products. This will include pharmacovigilance activities and interventions designed to identify, characterize, prevent or minimize risks relating to medicinal products.
- Ensure local and global risk management plan preparation and execution.
- Formulate clinical trial and post marketing risk management safety strategies.
- Perform drug safety signal detection activities of investigational and marketed products, develop evaluations of safety signals and make recommendations for safety signals.
- Manage and monitor benefit-risk evaluations to ensure favorable benefit-risk balance.
- Review ICSRs and provide follow-up guidance to Case Operations team.
- Review literature regarding products (including products from collaboration partners) to identify relevant information. Conduct reviews independently and in with external partners.
- Drive preparation of IND Annual Reports and/or DSURs for clinical trial programs, and PADERs and/or PSURs for marketed products.
- Perform Health Hazard Evaluations.
- Participate in the development and production of integrated summaries of safety, clinical overviews, and other registration documents.
- Drive the safety strategy for Reference Safety Information.
- Participate in internal safety process improvements and updates.
- Contribute to preparedness for regulatory authority inspection and internal audits of Pharmacovigilance.
- Contribute to the development and implementation of any preventative and/or corrective action plans as they pertain to specific identified deficiencies of policy, procedure, or practice in GRMSS.
- Review medical and safety content included in standard response letters prepared by Medical Affairs. Work with Medical Affairs to create and periodically revise standard communications that include specific adverse event information.
- Champion risk management safety strategy to internal and external stakeholders.
Skills And Qualifications
- MD or equivalent and 5-10 years of pharmaceutical/biotechnology or regulatory agency experience (5+ years in a PV or risk management role).
- MPH or relevant epidemiology experience in industry or academia.
- Experience in pharmaceutical industry activities outside the United States.
- Experience in clinical trial development and execution.
- In-depth knowledge of US/EU risk management/GVP landscape.
- Training or experience in oncologic or inflammatory diseases, or relating to clinical safety support of oncology, immunomodulatory, or other related products.
- Firsthand experience interacting with regulators with risk management issues.
- Experience as an active contributor with drug registrations.
- Board certification in internal medicine, pediatrics (primary care) or hematology/oncology.
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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