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.
- 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.