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- Tasks: Lead pharmacovigilance activities and ensure drug safety compliance.
- Company: Global biopharmaceutical leader focused on rare disease treatments.
- Benefits: Flexible remote work, competitive salary, and career advancement opportunities.
- Why this job: Join a top company making a real difference in patients' lives.
- Qualifications: Master’s degree in life sciences and 8+ years in drug safety.
- Other info: Dynamic role with a chance to impact global health.
The predicted salary is between 36000 - 60000 £ per year.
Senior Pharmacovigilance Manager – Biopharmaceuticals – Hertfordshire / Remote
Our client, a global biopharmaceutical company with plants across Europe and North America is looking for a Senior Pharmacovigilance Manager to join their team in the UK.
This is your chance to be part of one of the top players in the field of plasma-derived products, supplying high-quality medicines treating rare diseases, across the globe.
Essential Duties and Responsibilities for this Senior Pharmacovigilance Manager role include, but are not limited to, the following :
- Responsible for the management of case-processing activities through all phases of development, to properly address any ADRs / Special Situations possibly associated to medicinal products licensed / distributed by our client. and its subsidiaries.
- Ensures proper management of worldwide / national literature research in order to detect meaningful safety data.
- Ensures correct handling of data reconciliation activities with all the internal supportive functions as defined by Company procedures.
- Ensures proper management of Aggregate Reports (PSURs, PAERs, RMPs, AdCOs) of medicinal products licensed / distributed by our client and its subsidiaries.
- Ensures the compilation, update, review of Dossier and Printouts (SPC / PI) for the parts pertaining to Pharmacovigilance, in collaboration with the Global Regulatory Affairs department.
- Ensure support to the Clinical Research Department in drafting the Safety Study Plan (SSP), in the correct management of ADRs / ICSSRs from clinical studies / trials, in drafting the Investigator\’s brochure (IB) and the Development Safety Update Reports (DSUR).
- Ensures management of Reference Safety Information over time.
- Support both the EU QPPV and the PV Medical Unit, in all phases of the signal management process, from their detection to their communication, including the management of the identified actions.
- Collaborate with the corporate departments involved in the management of Post Authorization Safety Studies and the Patient Support Program, from the review of protocols / reports to the training of the personnel involved and the analysis of the data collected.
- Maintain awareness and ensure adherence to established and updated local and global processes as well as national and international regulations and guidelines for activities linked with his / her scope.
Desirable Experience :
- Master’s degree in life sciences field
- 8+ years of experience drug safety and pharmacovigilance in the pharmaceutical industry
- Experience in participating in Audits and Inspections
- Experience with use of safety databases, preferably Veeva Vault
- Knowledge of UK, FDA, EU, and international adverse event reporting regulations per ICH guidelines and ability to interpret and apply applicable regulations to resolve issues.
- Experience in the management of Aggregate Reports (PSUR / PAER / RMP).
- Demonstrated competence in obtaining, analysing, disseminating and reporting safety information in compliance with global regulations
- Experience with the preparation of investigational regulatory reports
- Proficiency in standard desktop software programs (Word, Excel, PowerPoint, Outlook)
If this role is of interest, please apply now.
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Senior Pharmacovigilance Manager employer: Quanta part of QCS Staffing
Contact Detail:
Quanta part of QCS Staffing Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Pharmacovigilance Manager
✨Tip Number 1
Network like a pro! Reach out to professionals in the pharmacovigilance field on LinkedIn or at industry events. A friendly chat can open doors that a CV just can't.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Knowing their pipeline and recent news will help you stand out and show your genuine interest in the role.
✨Tip Number 3
Practice common interview questions related to pharmacovigilance. Think about your past experiences and how they relate to the job description, especially around managing safety data and reports.
✨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 take that extra step.
We think you need these skills to ace Senior Pharmacovigilance Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Senior Pharmacovigilance Manager role. Highlight your relevant experience in drug safety and pharmacovigilance, especially any work with Aggregate Reports or safety databases like Veeva Vault.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about pharmacovigilance and how your background makes you a perfect fit for our team. Don’t forget to mention your experience with audits and inspections!
Showcase Your Skills: In your application, be sure to showcase your skills in data analysis and reporting. Mention any specific tools or software you’re proficient in, like Word, Excel, or PowerPoint, as these are essential for the role.
Apply Through Our Website: We encourage you to apply through our website for a smoother process. It helps us keep track of your application and ensures you don’t miss out on any important updates from us!
How to prepare for a job interview at Quanta part of QCS Staffing
✨Know Your Stuff
Make sure you brush up on your pharmacovigilance knowledge, especially around ADRs and Aggregate Reports. Familiarise yourself with the latest regulations from the UK, FDA, and EU. This will not only show your expertise but also your commitment to staying updated in the field.
✨Showcase Your Experience
Prepare specific examples from your 8+ years of experience that highlight your skills in managing case-processing activities and handling safety data. Use the STAR method (Situation, Task, Action, Result) to structure your responses and make them impactful.
✨Ask Smart Questions
At the end of the interview, don’t shy away from asking insightful questions about the company’s approach to pharmacovigilance or their current projects. This shows your genuine interest in the role and helps you gauge if the company is the right fit for you.
✨Be Ready for Scenario-Based Questions
Expect to face scenario-based questions that test your problem-solving skills in real-world situations. Think about how you would manage a signal detection or handle an audit. Practising these scenarios can help you respond confidently during the interview.
