At a Glance
- Tasks: Lead Pharmacovigilance and Medical Information activities, ensuring compliance and coordination with vendors.
- Company: Join CNX Therapeutics Ltd, a pioneering company in healthcare innovation.
- Benefits: Competitive salary, professional development, and a dynamic work environment.
- Other info: Opportunity for career growth in a fast-paced, ethical workplace.
- Why this job: Make a real impact in patient safety and compliance while leading innovative projects.
- Qualifications: Experience in healthcare or life sciences, with strong vendor management skills.
The predicted salary is between 60000 - 80000 £ per year.
About the role
The Senior Manager, Pharmacovigilance and Medical Information will be responsible for leading the provision and coordination of Pharmacovigilance (PV) and Medical Information (MI) activities for CNX Therapeutics Ltd (CNX) and its subsidiaries, closely coordinate activities with the UK/EU QPPV, vendors & Business Partners and ensure CNX and its subsidiaries are compliant with local PV legislation and the applicable Codes of Practice. The role requires being the subject matter expert on PV and MI; acting as the main point of contact for our vendors. You will be confident making decisions, take real ownership of your work and thrive in a fast-paced environment where priorities can shift quickly. You will also be highly organised, able to juggle multiple projects simultaneously and be proactive in driving tasks forward with minimal supervision.
Core role responsibilities
- Act as the main point of contact for all PV and MI related activities
- Coordinate with third-party PV and MI vendors and provide support in overseeing their compliance with contracts and relevant regulations
- Work closely with and support the appointed UK/EU QPPV to ensure oversight of all required PV processes
- Create and maintain PV and MI vendor agreements, including budget responsibilities for such agreements
- Review agreements created by other functions which impact PV
- Review and approve the UK/EU PV System Master File
- Monitor PV and MI vendor KPIs and metrics
- Review and approve MI standard responses and provide support to MI vendor for second line MI enquiries as required
- Create and maintain safety data exchange agreements (SDEAs) as required
- Collaborate with business partners to ensure that SDEA provisions are being adhered to
- Review, revise and author PV and MI SOPs and associated quality documents
- Proactively review and critique SOPs to support continuous improvement initiatives
- Ensure compliance with the General Data Protection regulation (GDPR) in relation to PV and MI data processing
- Act as the lead in PV audits and inspections of CNX
- Perform/maintain oversight of PV audits of business partners and PV/MI vendors
- Perform due diligence from a PV and MI perspective for potential future acquisitions
- Lead on PV and MI integration activities following mergers and acquisitions
Ethical and compliance responsibilities
Live the CNX Values. Maintain high standards of ethics and support the company in its efforts to have a pioneering approach to environmental, social and governance (ESG). To follow, promote and enforce relevant SOPs, Work Practices, and Company policies and procedures.
Required skills and experience
- Educated in a health care related or life science field or equivalent demonstrated experience is required
- Demonstrated capabilities in PV/MI vendor and partner management
- In-depth knowledge of EU/UK GVP, ICH requirements with the ability to operationalise legislation into compliant PV and MI processes, vendor oversight, and audit readiness
- A strategic thinker with the ability to work independently and a history of solving complex safety challenges
- Excellent teamwork and communication skills, with the ability to influence and partner effectively with cross-functional stakeholders
- Previous experience in line management is preferred
Senior Manager, Pharmacovigilance & Medical Information – 12 month FTC in London employer: CNX Therapeutics Ltd
At CNX Therapeutics Ltd, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. Our commitment to employee growth is evident through continuous professional development opportunities and a supportive environment that encourages autonomy and initiative. Located in a vibrant area, we offer competitive benefits and a chance to make a meaningful impact in the field of pharmacovigilance and medical information, ensuring our team members thrive both personally and professionally.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager, Pharmacovigilance & Medical Information – 12 month FTC in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmacovigilance and medical information fields. Attend industry events or webinars, and don’t be shy about introducing yourself. You never know who might have the inside scoop on job openings!
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of EU/UK GVP and ICH requirements. Be ready to discuss how you can operationalise legislation into compliant processes. Show them you’re not just a candidate, but the perfect fit for their team!
✨Tip Number 3
When you get that interview, come armed with examples of how you've successfully managed vendor relationships and compliance in the past. Share specific stories that highlight your strategic thinking and problem-solving skills. This will set you apart from the competition!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive and engaged. So, go ahead and show us what you’ve got!
We think you need these skills to ace Senior Manager, Pharmacovigilance & Medical Information – 12 month FTC in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to highlight your experience in Pharmacovigilance and Medical Information. We want to see how your skills align with the role, so don’t be shy about showcasing relevant projects or achievements!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re the perfect fit for this Senior Manager role. Share your passion for PV and MI, and how your previous experiences have prepared you for this fast-paced environment.
Showcase Your Decision-Making Skills:In your application, highlight instances where you've made confident decisions in challenging situations. We love candidates who take ownership of their work and can thrive under pressure, so share those stories!
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 shows you’re keen on joining our team at CNX Therapeutics!
How to prepare for a job interview at CNX Therapeutics Ltd
✨Know Your Stuff
Make sure you brush up on your knowledge of Pharmacovigilance (PV) and Medical Information (MI). Familiarise yourself with the latest EU/UK GVP and ICH requirements, as well as any recent changes in legislation. Being able to discuss these confidently will show that you're the subject matter expert they’re looking for.
✨Showcase Your Organisational Skills
Since the role involves juggling multiple projects, prepare examples that demonstrate your organisational skills. Think about times when you successfully managed competing priorities or led a project from start to finish. This will help illustrate your ability to thrive in a fast-paced environment.
✨Prepare for Scenario Questions
Expect questions that assess your decision-making and problem-solving abilities. Prepare for scenario-based questions where you might need to explain how you would handle compliance issues or vendor management challenges. Use the STAR method (Situation, Task, Action, Result) to structure your responses.
✨Emphasise Teamwork and Communication
This role requires excellent teamwork and communication skills. Be ready to share examples of how you've influenced cross-functional teams or collaborated with stakeholders. Highlighting your ability to work effectively with others will be key to demonstrating your fit for the position.
