At a Glance
- Tasks: Lead pharmacovigilance, oversee safety events, and support risk-benefit assessments.
- Company: Join a pioneering company focused on precision medicine in oncology.
- Benefits: Remote work, global exposure, and opportunities for career growth in drug safety leadership.
- Other info: Collaborate with cross-functional teams and maintain audit readiness.
- Why this job: Make a real impact in drug development and patient safety in a high-stakes environment.
- Qualifications: MD with 7+ years in Drug Safety and oncology clinical trial experience.
The predicted salary is between 63000 - 77000 £ per year.
Overview
In this role you will lead the pharmacovigilance function, overseeing safety events and medical review to support risk-benefit assessment.
You will contribute to safety data management, signal detection, and regulatory reporting across FDA, EMA, and ICH guidelines.
Working with CROs and internal teams, you will drive safety monitoring, audits readiness, and safety system governance to enable safe, compliant drug development and eventual commercialization.
This is a high-impact position in a precision‑medicine setting focused on oncology.
- Pay / Benefits
- Remote work
- opportunity to contribute to oncology programs
- global regulatory exposure
- collaboration with cross-functional teams
- focus on precision medicine
- career growth in drug safety leadership
Responsibilities
- Lead safety data review, signal detection, risk communication and mitigation.
- Provide medical expertise for SAE interpretation and regulatory safety reporting.
- Collaborate with CRO Safety Physicians and internal Medical Directors on safety monitoring and reporting (case and aggregate).
- Contribute to safety sections in protocols, reports, IBs, and ICFs; respond to safety questions from regulators and ethics bodies.
- Set up and run DSMBs or safety data review meetings.
- Participate in routine safety cohort reviews for Phase 1 dose escalation.
- Oversee safety systems and data management to ensure compliance and optimized access.
- Ensure SOPs and vendor governance for Drug Safety are robust.
- Plan for future Drug Safety development, including QPPV support and pharmacovigilance documentation.
- Maintain audit and inspection readiness of the function.
- Key requirements
- MD with a minimum of 7 years in Drug Safety activities in pharma/biotech
- Clinical trial experience with oncology safety, including at least 3 years in early development
- Experience authoring and providing input to drug-safety regulatory reports
- Regulatory agency interactions or inspections experience
- Strong knowledge of FDA, EU, ICH safety reporting and risk management requirements
- Solid medical knowledge in hematology/oncology trials and safety monitoring
- Proficiency with safety databases and standard computer applications
- Ability to respond quickly to emerging information and work in fast-paced environments
- Excellent written and oral communication for interfacing with vendors and stakeholders
- Strong collaboration, ownership, and accountability in team settings
- Less than 20% travel
- Experience with case processing in ARGUS
- Experience with Ao SE and patient safety narratives
- excellent communication
- collaboration
- ownership and initiative
- ARGUS safety database
- risk management
- signal detection
Safety Physician employer: Precision for Medicine
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