Safety Evaluation and Risk Management Lead

JR United Kingdom; Tadworth; On-site; GBP 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Safety Evaluation and Risk Management Lead to enhance risk management practices. This pivotal role involves developing best practices, providing strategic guidance, and acting as the key interface for risk management initiatives. The ideal candidate will possess strong analytical and project management skills, with a background in clinical research and regulatory requirements. Join a dynamic team committed to excellence in safety and risk management, where your expertise will drive impactful changes in the industry.

Qualifications

• Minimum 5 years pharma experience in medical, clinical, or pharmacovigilance.
• Advanced degrees preferred for leadership roles.

Responsibilities

• Develops and implements best practices in risk management planning.
• Leads PRMS meetings and manages supplier performance.

Skills

High-level analytical skills

Strategic thinking

Communication proficiency

Knowledge of clinical research

Project management skills

Collaboration skills

Education

B.S. in health science

M.S. in health science

Project management certification (PMP)

Six Sigma certification

Tools

MS Office

Job description

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Safety Evaluation and Risk Management Lead, Tadworth

Client: SRG

Location: Tadworth, United Kingdom

Job Category: Other

EU work permit required: Yes

Job Views: 3

Posted: 05.05.2025

Expiry Date: 19.06.2025

Job Description:

Primary Responsibilities:

1. Develops and implements best practices in risk management planning, including communication, minimization, and benefit/risk assessments, in collaboration with RAM Head.
2. Supports SSRM with strategic guidance on risk management, considering regulatory requirements and product risk profiles, including RMP initiatives.
3. Acts as the key interface between RAM and the Business Unit for oversight and tracking of RMP commitments, providing updates to the RMC.
4. Leads PRMS meetings, manages agendas, minutes, and actions, ensuring appropriate membership and external engagement.
5. Manages supplier performance and supports day-to-day communications.
6. Reports regularly on RMP milestones and performance via dashboards.
7. Creates and maintains project planning and documentation, including project charters, plans, reports, and deliverables.
8. Maintains project-related documentation and file structures.
9. Supports SSRM with strategic guidance, risk management education, and participates in audits and inspections.

Additional Leadership Activities:

• Supports risk management planning considering local regulations and product profiles.
• Prepares project documentation and provides risk management education.
• Participates in audits, inspections, and external safety forums.

Director RMPL Responsibilities:

• Acts as SME or BPO for Safety SOPs.
• Manages special projects and communications.
• Provides guidance, coaching, and training to RMPLs.
• Engages with external safety experts and forums.
• Implements standardization opportunities in Safety.
• Evaluates issues and strategizes to meet or accelerate timelines.
• Influences safety, regulatory, and medical teams for risk management development.

Technical Skill Requirements:

• High-level analytical skills, detail-oriented, organized.
• Strategic thinking and communication proficiency.
• Knowledge of clinical research, safety, regulatory requirements, and risk management regulations.
• Technical expertise in the discipline.
• Ability to evaluate and document data scientifically.
• Knowledge of organizational development and success in strategy implementation.
• Project management skills, including managing multiple projects and budgets.
• Proficiency in MS Office and departmental systems.
• Strong collaboration skills across functions and geographies.

Qualifications:

• B.S., M.S. in health science; advanced degrees preferred.
• Senior Manager RMPL: Minimum 5 years pharma experience in medical, clinical, or pharmacovigilance with focus on drug safety risk management.
• Director RMPL: Minimum 10 years pharma experience with similar focus.
• Knowledge of global safety regulations and experience in risk management planning.
• Strong analytical, communication, negotiation, and organizational skills.
• Project management certification (PMP) and Six Sigma preferred.