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- Tasks: Lead safety signal management and ensure drug safety compliance in clinical trials.
- Company: Global biopharmaceutical company focused on healthcare innovation and sustainability.
- Benefits: Competitive pay up to £100 p/h, remote work, and a 12-month contract.
- Other info: Join a dynamic team with opportunities for professional growth in a vital industry.
- Why this job: Make a real impact on patient safety and contribute to groundbreaking healthcare solutions.
- Qualifications: Advanced scientific degree and expert experience in pharmacovigilance and safety signal management.
My client, a global biopharmaceutical company with a goal of contributing to healthcare innovation and environmental sustainability and which is focused on improving people's quality of life, specialising in Oncology, neurology and rare diseases, has a position available for a Senior Pharmacovigilance Scientist specialising in Safety signal management / detection to join their Pharmacovigilance team on a 12-month initial contract.
Remote 12 Month + Contract INSIDE IR35 PAYE - Up to £80 p/h (depending on experience) Umbrella - Up to £100 p/h (depending on experience)
As the Senior Pharmacovigilance Scientist, you will serve as a product lead for Pharmacovigilance activities within Safety. The Senior PV Scientist is responsible for overseeing and leading the process for safety signal management activities (detection, evaluation, prioritisation, and assessment of safety signals related to drug safety), aggregate reports (PSURs, DSURs, Line Listings, RMPs), responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV medical activities.
The Senior PV Scientist also serves as a Subject-Matter Expert for Safety and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product-specific information. In this capacity, the Sr. PV Scientist is critical to ensuring products in clinical trials continue to maintain good standing with countries where studies are ongoing to ensure clinical studies are completed, and for marketed products, ensures the marketing authorisation remains in good standing.
What you'll need to succeed:
- A scientific degree, advanced degree preferred (e.g., M.Sc., PhD, MPH, PharmD).
- Expert experience of pharmaceutical industry and pharmacovigilance, including safety signal management - detection, evaluation, prioritisation, and assessment of safety signals related to drug safety.
- Expert experience of Filing EU responses.
- Expert experience of HA (Health Authority) responses.
- Expert knowledge of Risk Management and RMP's.
- Strong knowledge of pre- and post-marketing pharmacovigilance legislation (CTR, GVP Modules, ICH/CIOMS).
- Experience with EMA and FDA regulatory submissions.
Before you apply for this position, it is vital that you are in possession of a UK passport or relevant visa to work without restrictions in the UK and must be based in the UK.
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins on (phone number removed).
Senior Pharmacovigilance Scientist - Signal management / RMP in City of London employer: Hays Life Sciences
Contact Detail:
Hays Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Pharmacovigilance Scientist - Signal management / RMP in City of London
✨Tip Number 1
Network like a pro! Reach out to your connections in the biopharmaceutical field, especially those in pharmacovigilance. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of safety signal management and relevant regulations. We recommend practising common interview questions and scenarios related to drug safety to show you're the expert they need.
✨Tip Number 3
Don’t just apply anywhere; focus on companies that align with your values, like those committed to healthcare innovation. Use our website to find roles that excite you and match your expertise in pharmacovigilance.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can keep you top of mind. Share your enthusiasm for the role and reiterate how your skills in safety signal management make you a perfect fit.
We think you need these skills to ace Senior Pharmacovigilance Scientist - Signal management / RMP in City of London
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to highlight your experience in pharmacovigilance and safety signal management. We want to see how your skills align with the role, so don’t be shy about showcasing your relevant achievements!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about this role and how your background makes you the perfect fit. We love seeing enthusiasm and a personal touch!
Highlight Relevant Experience: When detailing your experience, focus on specific projects or roles that relate to safety signal management and regulatory submissions. We’re looking for concrete examples that demonstrate your expertise in the field.
Apply Through Our Website: Don’t forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it’s super easy – just a few clicks and you’re done!
How to prepare for a job interview at Hays Life Sciences
✨Know Your Stuff
Make sure you brush up on your pharmacovigilance knowledge, especially around safety signal management and risk management plans. Be ready to discuss your experience with EU and FDA submissions, as well as any relevant regulations. This will show that you're not just familiar with the theory but have practical insights too.
✨Prepare for Scenario Questions
Expect to be asked about specific scenarios related to safety signal detection and evaluation. Think of examples from your past work where you successfully managed safety signals or responded to health authority queries. Use the STAR method (Situation, Task, Action, Result) to structure your answers clearly.
✨Show Your Team Spirit
As a Senior Pharmacovigilance Scientist, you'll be working with cross-functional teams. Highlight your collaboration skills and give examples of how you've worked effectively with others in the past. This could include working with clinical trial teams or liaising with regulatory bodies.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions! Inquire about the company’s approach to safety signal management or how they handle regulatory changes. This shows your genuine interest in the role and helps you assess if the company is the right fit for you.