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, flexible working options, and opportunities for professional growth.
- Other info: Be part of a team that values ethics and continuous improvement.
- Why this job: Make a real impact in patient safety while thriving in a dynamic environment.
- Qualifications: Experience in healthcare or life sciences, with strong vendor management skills.
The predicted salary is between 60000 - 75000 € 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 employer: Integratedcooling
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 where your contributions are valued. Located in a vibrant area, we offer competitive benefits and the chance to make a meaningful impact in the field of pharmacovigilance and medical information.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager, Pharmacovigilance & Medical Information – 12 month FTC
✨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 researching CNX Therapeutics Ltd and its values. Understand their approach to compliance and safety data management. Tailor your responses to show how your experience aligns with their needs, especially in vendor management and regulatory compliance.
✨Tip Number 3
Showcase your organisational skills! During interviews, share examples of how you’ve successfully managed multiple projects or led teams in fast-paced environments. Highlight your proactive approach to problem-solving and decision-making.
✨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 genuinely interested in joining our team at CNX. Let’s make it happen!
We think you need these skills to ace Senior Manager, Pharmacovigilance & Medical Information – 12 month FTC
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Manager role. Highlight your experience in Pharmacovigilance and Medical Information, and don’t forget to showcase your vendor management skills. We want to see how you can bring your expertise to CNX!
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 role. Mention specific experiences that align with the job description and show us your passion for PV and MI. Remember, we love a good story!
Showcase Your Organisational Skills:Since the role requires juggling multiple projects, make sure to highlight your organisational skills in your application. Share examples of how you've successfully managed competing priorities in the past. We need someone who can thrive in a fast-paced environment!
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 us you’re keen on joining the StudySmarter team!
How to prepare for a job interview at Integratedcooling
✨Know Your Stuff
Make sure you brush up on your knowledge of Pharmacovigilance (PV) and Medical Information (MI). Familiarise yourself with EU/UK GVP and ICH requirements, as well as any recent changes in legislation. Being able to discuss these topics confidently will show that you're the subject matter expert they’re looking for.
✨Showcase Your Organisational Skills
Since the role requires juggling multiple projects, prepare examples from your past experiences where you successfully managed several tasks at once. Highlight how you prioritised and drove tasks forward, especially in fast-paced environments. This will demonstrate your ability to thrive under pressure.
✨Prepare for Compliance Questions
Expect questions about compliance with local PV legislation and GDPR. Be ready to discuss how you've ensured compliance in previous roles, and think of specific instances where you’ve had to navigate complex regulatory environments. This will show your understanding of the ethical responsibilities tied to the role.
✨Engage with the Interviewers
Don’t just answer questions; engage with your interviewers. Ask insightful questions about their current PV and MI processes, or how they handle vendor management. This shows your genuine interest in the role and helps you assess if the company aligns with your values and work style.
