We are seeking an experienced Senior Pharmacovigilance (PV) Operations Specialist (UK) to take a leading role in ensuring the highest standards of patient safety and regulatory compliance across a growing clinical-stage environment for one of valued clients. This is a hybrid position based in Cheshire, with on-site collaboration expected twice per week.
In this role, you will act as the UK Qualified Person for Pharmacovigilance (QPPV), providing strategic and operational leadership across pharmacovigilance activities. You will work closely with cross-functional teams and external partners to support the development and regulatory progression of an innovative oncology pipeline.
Everything You Need to Know About the Role
As the senior member of the safety function, you will play a critical role in both pre-approval and post-marketing pharmacovigilance activities, ensuring robust oversight of safety data and compliance with global regulatory requirements.
Key aspects of the role include:
- Leading the preparation, review, and submission of safety data packages for regulatory filings, including NDAs and Integrated Summaries of Safety (ISS)
- Acting as the UK QPPV, ensuring compliance with UK and global pharmacovigilance regulations
- Providing ongoing safety surveillance, including signal detection, trend analysis, and benefit–risk evaluation
- Overseeing end-to-end ICSR processing across clinical trials, spontaneous reports, and post-marketing sources
- Managing and governing pharmacovigilance partners and vendors to ensure quality and compliance
- Supporting and reviewing expedited and periodic safety reports (e.g., SUSARs, SAEs, DSURs, PSURs/PBRERs)
- Maintaining inspection readiness and supporting regulatory inspections, audits, and internal reviews
- Leading safety data reconciliation activities to ensure accuracy and consistency across systems
- Identifying and managing safety risks, including CAPA activities
- Collaborating cross-functionally with Clinical Operations, Medical Affairs, Regulatory, Quality, and external partners
- Contributing to SOP development, training, and continuous improvement initiatives
Experience and Qualities that Make You a Strong Fit
You are a proactive and detail-oriented pharmacovigilance professional who thrives in a dynamic, collaborative environment.
We are looking for:
- A degree in life sciences, pharmacy, nursing, public health, or a related field (advanced degree desirable)
- Extensive pharmacovigilance experience within biotech, CRO, or pharmaceutical environments
- Demonstrated experience supporting NDA submissions and preparing safety data packages
- Strong working knowledge of global PV regulations (FDA, EMA, ICH, CIOMS)
- Hands-on experience with ICSR processing and safety databases (e.g., Argus, ARISg, Veeva Vault Safety)
- Experience across both clinical trial and post-marketing safety
- Proven ability to oversee vendors and CROs effectively
- Experience supporting audits and regulatory inspections
- Strong analytical skills with the ability to interpret complex safety data and develop benefit–risk assessments
- Excellent communication skills with a collaborative, cross-functional mindset
You will also bring the following personal qualities:
- Integrity, accountability, and reliability
- Strong organisational skills with the ability to manage multiple priorities
- A team-oriented approach with a commitment to high-quality outcomes
- Confidence to act as QPPV and provide leadership in safety governance
What’s on Offer
- A hybrid working model with flexibility and collaboration
- Exposure to cutting-edge oncology drug development
- A collaborative and supportive team environment
- The chance to contribute directly to improving outcomes for patients with serious diseases
- Professional growth within a fast-paced, science-driven organisation
Could This Role Be for You?
If you are a motivated pharmacovigilance professional ready to step into a senior role with QPPV responsibility, this could be an excellent opportunity to make a meaningful impact.
This position would suit someone who enjoys balancing strategic oversight with hands-on operational involvement, and who is passionate about ensuring patient safety while contributing to the advancement of innovative therapies.
If you’re looking for your next challenge in a collaborative and purpose-driven environment, we’d love to hear from you, apply today!
Please note this role does not offer Sponsorship.