Safety Evaluation and Risk Management Lead

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

Job summary

An established industry player is seeking a Senior Manager for Risk Management Planning to lead strategic initiatives in risk management. This role involves developing best practices, managing supplier performance, and ensuring compliance with regulatory requirements. The ideal candidate will possess strong analytical skills, strategic thinking capabilities, and a background in clinical research or pharmacovigilance. Join a dynamic team where your expertise will drive impactful risk management solutions and enhance safety protocols across projects. This position offers an exciting opportunity to influence safety and regulatory practices in a collaborative environment.

Qualifications

• 5+ years pharma experience in medical, clinical, or pharmacovigilance.
• Knowledge of global safety regulations and risk management planning.

Responsibilities

• Develops best practices in risk management planning and communication.
• Leads project management and documentation for risk management processes.

Skills

Analytical Skills

Organizational Skills

Strategic Thinking

Communication Skills

Project Management

Negotiation Skills

Interpersonal Skills

Education

B.S. in Health Science

M.S. in Health Science

PharmD

Ph.D.

Tools

MS Word

MS Excel

MS PowerPoint

Job description

Job Description

Primary Responsibilities

1. In collaboration with RAM Head, develops/evolves/implements best practices in risk management planning, including risk communication, risk minimization, and in benefit/risk assessment methodologies.
2. Supports SSRM with strategic guidance for risk management planning, considering local regulatory requirements, risk management best practices, and product-specific risk profiles; develops and implements RMP initiatives within the client portfolio.
3. Serves as the key interface between RAM and the BU regarding oversight of RMP implementation and tracking commitments, providing periodic updates to the RMC.
4. Leads PRMS using effective leadership and process management techniques. Builds agendas, prepares minutes, drives actions to completion, and manages documentation and meeting attendance, including external expert engagement.
5. Manages supplier performance/delivery relative to SOW; supports daily supplier communications.
6. Provides regular reporting on RMP milestones/performance via dashboards aligned with KPIs and regulatory commitments.
7. Creates and maintains project planning and execution documentation, including project charters, plans, progress reports, activity logs, and deliverables like RMP submissions.
8. Updates and maintains project documentation per risk management processes and file structures.

Senior Manager RMPL

In addition to the above, demonstrates leadership qualities by:

1. Supporting SSRM with strategic guidance considering local regulations and risk profiles, and developing RMP initiatives.
2. Creating and maintaining project documentation.
3. Providing risk management education internally and externally.
4. Participating in audits, inspections, and response preparations.

Director RMPL

In addition to previous responsibilities, the Director (level 15) RMPL:

1. Acts as SME or BPO for Safety SOPs.
2. Manages special projects and communications.
3. Guides and coaches less experienced RMPLs, participates in training, and resolves issues.
4. Recommends and manages external safety consultations and forums.
5. Implements standardization opportunities in Safety.
6. Evaluates issues and strategizes to meet or accelerate timelines.
7. Influences safety, regulatory, and medical teams for risk management development and implementation.

Technical Skill Requirements

• High-level analytical skills, detail-oriented, independent, excellent organizational skills.
• Strategic thinking with strong communication and presentation skills.
• Knowledge of clinical research, safety, regulatory requirements, and risk management regulations.
• Technical expertise in key discipline concepts.
• Ability to evaluate and document data scientifically.
• Knowledge of organizational development principles and strategies.
• Experience managing multiple projects and processes, meeting deadlines, and managing budgets.
• Proficiency in MS Word, Excel, PowerPoint, and relevant systems.
• Skills in matrix partnerships and collaborative relationships across global teams.

Qualifications

• B.S., M.S. in health science; advanced degrees (PharmD, Ph.D.) preferred.
• Senior Manager RMPL: Minimum 5 years pharma experience in medical, clinical, or pharmacovigilance, focusing on drug safety risk management.
• Director RMPL: Minimum 10 years pharma experience with a focus on drug safety risk management.
• Knowledge of global safety regulations and experience in risk management planning and RMPs.
• Strong analytical, communication, negotiation, and interpersonal skills.
• Organizational and project management skills, familiarity with performance metrics.
• Project management and Six Sigma certifications preferred.