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Knowledge: Strong understanding of pharmacovigilance regulatory requirements (FDA, EMA, MHRA, ICH guidelines) and GVP.
Safety Physician - Early Phase Immunology
- Posted 27 January 2025
- LocationCambridge
- Job type Contract
- Reference209924
- Contact NameSam Frost
Job description
Job Title: Drug Safety Physician – Immuno-Oncology
Location: Remote (US or UK-based candidates)
Employment Type: Contract, Part-Time (20 hours per week)
About the Role:
BioTalent is proud to support an innovative US-based small biotech company dedicated to developing cutting-edge therapies targeting cancer. As part of their growth, they are seeking an experienced Drug Safety Physician with expertise in immuno-oncology to provide strategic and operational oversight for their drug safety and pharmacovigilance activities.
This is a part-time contract role, offering an exciting opportunity to contribute to the safety management of novel cancer therapies in development.
Key Responsibilities:
- Provide medical oversight and guidance for the pharmacovigilance activities of the company’s immuno-oncology assets, ensuring patient safety remains a top priority.
- Perform medical review and analysis of individual case safety reports (ICSRs) and aggregated safety data to identify potential safety signals.
- Collaborate with cross-functional teams, including clinical development, regulatory affairs, and medical affairs, to assess safety data and provide risk management recommendations.
- Author and review key safety documents, including safety management plans, risk management plans (RMPs), Development Safety Update Reports (DSURs), and Investigator Brochures (IBs).
- Support the preparation and submission of safety reports to regulatory agencies (e.g., SUSARs, periodic safety reports).
- Participate in Safety Review Committees and provide input into the development of safety narratives and strategies.
- Act as the medical safety expert in discussions with external stakeholders, such as regulatory agencies, investigators, and key opinion leaders (KOLs).
- Stay up to date with the latest developments in immuno-oncology and drug safety to inform the company’s safety strategy.
Candidate Profile:
Qualifications:
- Education: MD or equivalent medical degree with board certification in oncology, immunology, or a related field preferred.
- Experience:
- 5+ years of pharmacovigilance/drug safety experience within the pharmaceutical, biotechnology, or CRO environment.
- Demonstrated expertise in immuno-oncology and a deep understanding of immune-related adverse events (irAEs).
- Experience supporting early- and late-phase clinical trials, particularly in oncology, is highly desirable.
Skills and Attributes:
- Proficient in analyzing and interpreting safety data, with excellent clinical judgment.
- Strong written and verbal communication skills, with the ability to articulate complex safety issues to internal and external stakeholders.
- Collaborative and flexible, with a problem-solving mindset and the ability to adapt in a fast-paced environment.
- Highly organized, with a keen attention to detail and the ability to manage multiple priorities effectively.
- Comfortable working independently in a remote environment while maintaining close collaboration with global teams.
What’s on Offer:
- Part-time, flexible contract role (20 hours per week) with remote working arrangements.
- Competitive hourly rate, commensurate with experience.
- Opportunity to work with a pioneering biotech company developing breakthrough cancer therapies.
- The chance to make a meaningful impact in advancing immuno-oncology treatments for patients.
How to Apply:
If you are a skilled Drug Safety Physician with immuno-oncology experience, we’d love to hear from you! Please send your CV for consideration.
