Overview

In addition to working with GPV stakeholders, the Risk Management Director will partner with the Medical Sciences, Statistics, Regulatory, Legal, Pre-Clinical disciplines, European Safety Office and other key stakeholders to effectively plan risk management strategies that enhance Therapeutic Area Strategy and project/product life-cycle management.

Essential Job Responsibilities:

  • Leads the development of policy for project/product risk management strategy (D-Risk Management Plan) and internal and regulatory action plans for real and theoretical safety risks in partnership with the project/product team, and advises product teams to ensure clear and balanced communication to senior management.
  • Advises product teams in a manner to optimize the implementation of risk management strategies for specific risk assessment activities and documents, coordinating and/or authoring documents as appropriate, providing project teams/senior management with a comprehensive recommendation on risk management strategy.
  • Organizes and provides administrative support to the appropriate governance committees by ensuring that routine updates are provided.
  • Advises product teams for development of Investigator Brochure activities where appropriate (i.e. “Advice to Investigators” Section).
  • Oversees the policy that is developed for teams that will be responsible for authoring, updating, and maintains the Risk Management Plan (RMP, EU-RMP, REMS), ensuring compliance with current local regulatory requirements. The RML advises teams to ensure that postmarketing risk management activities are aligned with the Risk Management Plan.
  • Advises teams to lead development of peri- and post-approval safety commitments during the endgame and approval phases, and may assist in negotiating these commitments with regulators; coordinates post-approval safety commitments.
  • Assists teams with communication and knowledge transfer across project/product teams, Therapeutic Areas, and GPV regarding risk management positions, policies and strategies.
  • Creates and fosters an environment of partnership and collaboration between GPV and the project/product team. Develops and sustains constructive relationships with preclinical disciplines, Medical Affairs and other APGD teams.
  • Supports the Global RM Head with designing the risk management function Global PV, timely implementation, and evaluation of the function.
  • Advises teams to ensure risk management awareness and communication at investigator meetings, as appropriate.

Qualifications/Required:

  • MD or advanced health related sciences degree (PhD/PharmD); or equivalent.
  • At least 5-10 years pharmaceutical/health related industry experience in one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development, with at least 3-4 years of direct experience in risk management (in a global setting preferred).
  • Key leadership responsibilities in previous role(s) preferred.
  • Global responsibilities in previous role(s) preferred.
  • Strategic thinking, Organizational, Leadership. Results-oriented performance. Team player.
  • Excellent knowledge of ICH, US & EU regulations and requirements for pharmacovigilance (experience with world-wide safety reporting regulations and guidelines required).
  • Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally.
  • Proven ability to effectively lead cross-functional teams with respect to risk management activities and to influence where direct reporting line relationships do not exist.

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