Risk Management Project Lead

ZipRecruiter; Cotswold District; On-site; GBP 60,000 - 100,000

Job description

Job Description

Primary Responsibilities

1. Serves as the key interface between RAM and the BU in matters related to oversight of implementation and tracking of commitments included within the RMP and provides periodic updates regarding the status of implementation to the RMC.
2. Leads PRMS using effective leadership and process management techniques. Builds appropriate agendas, provides draft and final minutes, and drives the actions to completion. Responsible for the storage and tracking of action items from meetings. Ensures appropriate membership attendance for internal and external meetings, including external expert engagement and briefing.
3. Manages supplier performance/delivery relative to defined and agreed upon SOW; supports managing day-to-day supplier communications.
4. Provides regular reporting on all aspects of RMP milestones/performance per specific targets as defined by key performance indicators (KPIs) and/or regulatory commitments through maintenance and presentation of project performance dashboards.
5. With oversight, creates/maintains project planning and execution documentation including, but not limited to, project charters, detailed project plans/milestones, progress reports, activity logs, and deliverables, i.e., RMP submissions.
6. Updates/maintains assigned project-related documentation as per defined in risk management processes and file structure on designated system.

Senior Manager RMPL

In addition to the responsibilities listed above, a Manager RMPL will be required to engage in the following activities and demonstrate the above and following qualities in a leadership capacity:

1. Supports SSRM with strategic guidance for risk management planning, taking into consideration local regulatory requirements, risk management best practices, and product-specific risk profile, and development and implementation of RMP initiatives for products within the client portfolio.
2. Creates/maintains project planning and execution documentation including, but not limited to, project charters, detailed project plans/milestones, progress reports, activity logs, and deliverables, i.e., RMP submissions.
3. Provides risk management education to internal and external colleagues.
4. With oversight, participates in audits and inspections; prepares and coordinates responses; participates in inspection readiness.

Qualifications (i.e., education, experience, attributes)

1. B.S., M.S. in health science.
2. Advanced degree (Pharm.D, or Ph.D, or equivalents).
3. Senior Manager RMPL - Minimum 5 years of broad and progressive pharma experience in medical, clinical or pharmacovigilance but with a clear focus on drug safety risk management.
4. Knowledge of global safety regulations and guidelines, or equivalent.
5. Demonstrated experience in global drug safety risk management planning activities and generating RMPs.
6. Demonstrated strength in analytical skills and attention to detail.
7. Demonstrated strength in oral/written communication, negotiation, and interpersonal skills.
8. Demonstrated organizational/project management skills.
9. Familiarity with management of performance metrics.
10. Significant knowledge of organization processes and matrix-based decision-making is required.
11. Project management certification (PMP) and Six Sigma Certification.