At a Glance
- Tasks: Lead safety data review and collaborate on oncology-focused safety strategies.
- Company: Dynamic pharma/biotech company with a focus on innovative oncology solutions.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Fast-paced environment with strong emphasis on collaboration and teamwork.
- Why this job: Make a real impact in drug safety and patient outcomes in oncology.
- Qualifications: MD with 7+ years in Drug Safety and oncology clinical trial experience.
The predicted salary is between 75600 - 92400 £ per year.
Overview
In this role you lead the pharmacovigilance function, overseeing medical review and safety processing across all event types.
You will provide clinical safety input for data management, signal detection, and risk-benefit evaluations to support regulatory submissions.
You will collaborate with CROs, Medical Directors, and safety teams to ensure compliant, timely safety reporting and risk management.
The position offers impact by strengthening safety governance, audits readiness, and safety strategy in an oncology-focused portfolio.
Responsibilities
- Lead safety data review, signal detection, and risk communication across safety activities
- Provide medical and drug safety input for clinical trial data interpretation and SAE reviews
- Collaborate with CRO Safety Physicians, Medical Directors, and Clinical Scientists on safety monitoring and reporting
- Contribute to cross-functional safety sections in documents (protocols, reports, IBs, ICFs) and regulatory responses
- Set up and run DSMBs or safety data review meetings
- Participate in safety cohort reviews for early-phase dose escalation
- Oversee safety systems and vendor governance for compliant safety data management
- Develop safety processes for regulatory filings and pharmacovigilance systems such as PSMF and QPPV support
- Ensure audit and inspection readiness of the Drug Safety function
- Key requirements
- MD
- minimum 7 years in Drug Safety related activities in pharma/biotech
- clinical trial experience with oncology safety; at least 3 years in early clinical development
- experience authoring and reviewing drug-safety regulatory reports
- successful involvement in regulatory agency interactions or inspections
- strong knowledge of FDA, EU, ICH regulatory requirements for safety reporting and risk management
- familiarity with hematology/oncology safety concepts
- proficiency with safety databases and MS Office
- ability to multitask in a fast-paced environment
- excellent communication and collaboration skills
- experience with case processing in ARGUS and Ao SE
- strong communication skills
- collaboration and cross-functional teamwork
- proactive and results-driven
- ARGUS case processing
- Ao SE analysis and safety narratives
- safety data management and reporting
Safety Physician employer: Precision Medicine Group
At Precision Medicine Group, we pride ourselves on fostering a dynamic and inclusive work culture that empowers our employees to thrive. As a Principal Innovation Business Analyst, you will enjoy the flexibility of remote work from the UK while collaborating with cross-functional teams to drive meaningful change in healthcare through innovative AI solutions. We offer robust professional development opportunities, a commitment to employee well-being, and a supportive environment that values creativity and strategic thinking.
StudySmarter Expert Advice🤫
We think this is how you could land Safety Physician
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Precision Medicine Group. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Precision Medicine Group.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Precision Medicine Group. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Precision Medicine Group is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Safety Physician
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Precision Medicine Group!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Precision Medicine Group that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Precision Medicine Group!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Precision Medicine Group, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Precision Medicine Group
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Precision Medicine Group that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Precision Medicine Group’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
