At a Glance
- Tasks: Conduct medical reviews and collaborate on safety assessments for drug products.
- Company: Leading pharmaceutical company focused on patient safety and innovation.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Exciting role with potential for cross-functional collaboration and career advancement.
- Why this job: Join a dynamic team making a real difference in drug safety and patient care.
- Qualifications: Must be a qualified physician with experience in pharmacovigilance preferred.
The predicted salary is between 80000 - 100000 £ per year.
- Job Function
- Product Safety
- Job Sub Function
- Product Safety Risk Management MD
- Job Category
- Scientific/Technology
- All Job Posting Locations
- High Wycombe, Buckinghamshire, United Kingdom
Job Description
The employee is acquainted with the annual company and division goals and is aware of how he/she/they can influence these through his/her/their performance.
Essential Job Duties And Responsibilities
- Medical review
- May perform medical review of Individual Case Safety Reports (ICSRs) from all case types
- Provide support for the Director, MRSP as needed
- Liaise with MSO, primary MRSP, Molecule Responsible Physician (MRP), Safety Analysis Scientist (SAS) on operational aspects of Adverse Drug Reaction (ADR) determination and RSI table annual updates
- Prepare slides for Proactive Safety Review and analyze the applicable data in aggregate
- May analyze and assess Critical Cases (DME, EVOI, etc.)
- Detect single case signals/through validation
- Member of Safety Management Team
- May participate in Signal Evaluation
- Ensure Follow-up of all critical case/ Events of Special Interest (Risk Management Plan (RMP) identified risks)
- Evaluate Individual Case Safety Report (ICSRs) for potential product quality issues (including device malfunctions, if applicable)
- Perform aggregate review of cases in line listings
- PBRER/PADER activities
- Investigator Brochure activities
- Watchlist activities
- Targeted Follow-up Questionnaires creation/update
- Vendor oversight activities as assigned
- Additional ad hoc activities that may require physician input, example
- Standard Operating Procedures (SOPs)
- CAPAs
- Audits/inspection activities
- Lead cross functional projects/teams as assigned
- Minimum Qualification
- A Physician (MD or equivalent) is required.
- Medical specialization is preferred.
- A minimum of 1 year in clinical practice after postgraduate training program is preferred.
- A minimum of 3 years of experience in industry, academia or patient care settings is required.
- Direct experience in pharmacovigilance is preferred. Limited PV experience will be considered on a case-by-case basis in the context of the applicant’s overall application.
- Experience and knowledge of Good Clinical Practices is required.
- Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers in a team-oriented, matrix environment is required.
- Fluent in written and spoken English.
- Working knowledge of the use of Microsoft suite of software products, including Excel and Word.
- Must be able to work independently with minimum supervision to meet tight deadlines.
- Other Requirements
- Not applicable
- Required Skills
None listed.
Preferred Skills
Clinical Operations, Compliance Management, Compliance Risk, Cross-Functional Collaboration, Developing Others, Medicines and Device Development and Regulation, Quality Control (QC), Research Ethics, Risk Management, Safety Investigations, Safety-Oriented, Serious Adverse Event Reporting, Standard Operating Procedure (SOP), Surveillance, Tactical Planning, Team Management, Technical Credibility
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Medical Review Safety Physician, Associate Director employer: Johnson & Johnson
Johnson & Johnson in High Wycombe is an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration. Employees benefit from comprehensive growth opportunities, competitive compensation, and a commitment to compliance excellence, making it a rewarding environment for those passionate about quality systems and regulatory standards.
StudySmarter Expert Advice🤫
We think this is how you could land Medical Review Safety Physician, Associate Director
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Johnson & Johnson. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
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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 Johnson & Johnson.
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If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Johnson & Johnson. 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 Johnson & Johnson is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Medical Review Safety Physician, Associate Director
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 Johnson & Johnson!
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 Johnson & Johnson 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 Johnson & Johnson!
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 Johnson & Johnson, 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 Johnson & Johnson
✨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 Johnson & Johnson 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 Johnson & Johnson’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.
