System One Services Medical Director, Global Risk Management in Wilmington, Delaware

Medical Director, Global Risk ManagementWilmington, Delaware

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Type:Direct-Hire

Category:Scientific & Clinical

Job ID:127333

Date Posted:04/09/2018

Reputable Pharmaceutical Company is seeking a Medical Director - Global Risk Management to join their team. This individual would have a strong background in PV or Risk Management with in the pharmaceutical or biotech industry.

  • Direct Hire

  • Relocation Package

  • Competitive base salary with annual bonuses

Responsibilities

  • Lead and direct all safety risk management activities for assigned products, overseeing Safety Management Team

  • Formulate clinical trial and post marketing risk management safety strategies that are in alignment with the company‚Äôs drug development and commercialization strategies

  • Ensure local and global risk management plan preparation and execution throughout a medicinal products life-cycle

  • Perform drug safety signal detection activities for portfolio of development and marketed products develop medically reasonable evaluations of safety signals and make specific actionable and defensible recommendations for confirmation or refutation of safety signals

  • Medically review individual case safety reports ICSRs and provide follow up guidance to case operations team to ensure consistent high quality

  • Review periodic literature surveys of new and important information regarding products as well as relevant products from collaboration partners potentially impacting human safety

  • Participate significantly in the development and production of integrated summaries of safety clinical overviews and other registration documents for new and supplemental NDAs and/or ex US new drug submissions for late phase drug development candidates and marketed products in conjunction with Clinical Development Medical Writing Statistics and Regulatory Affairs

  • Contribute to preparedness for regulatory authority inspection and internal audits of Pharmacovigilance and 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 RMSS

  • Review medical and safety content included in standard response letters prepared by Medical Affairs as necessary and work with Medical Affairs to create and periodically revise standard communications that include specific adverse event AE information

  • Champion risk management safety strategy to internal (eg Clinical Development Medical Affairs Regulatory Affairs Quality Assurance Commercial Translational & Experimental Medicine and Legal and external stakeholders)

  • Serve as the RMSS medical representative for joint clinical development programs with external partners as designated by the Head RMSS

Requirements

  • Obtain an MD or DO

  • 5 years total pharmaceutical / biotechnology industry experience of which 2 years will have been in a pharmacovigilance or risk management role

  • In depth knowledge of USEU risk management

  • GVP landscape

  • First hand experience interacting with regulators with risk management issues

  • Experience as an active contributor with drug registrations CSRs ISS Clinical

  • MPH or relevant epidemiology experience in industry or academia Board certification in internal medicine or pediatrics primary care or hematology or oncology specialty- preferred

  • Experience in global clinical trial development and execution

  • Training or experience in oncology or inflammatory diseases or clinical safety support of oncology immunomodulatory or other related products

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