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Pharmacovigilance Manager (RP for EudraVigilance | CRO | Argus)
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Pharmacovigilance (PV) Manager
Hartley Wintney, Hampshire (Hybrid: 2 days onsite per week)
£competitive + Bonus + Private Medical + Pension
Please note: applicants must have CRO pharmacovigilance experience, be registered as an RP for EudraVigilance, have strong Argus Safety experience, and possess clinical trial pharmacovigilance expertise including DSUR authorship.
I'm working with a specialist drug development consultancy supporting pharmaceutical and biotech organisations across global clinical development and pharmacovigilance programmes.
This is a hands-on PV Manager position for someone looking to take ownership of client safety programmes while combining technical pharmacovigilance expertise with project leadership and client engagement. You'll oversee complex global PV activities across clinical trial and post-marketing products, working with clients across the UK, Europe, US and Latin America.
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Key Responsibilities
- Leading client pharmacovigilance programmes from start to finish
- Acting as the RP for EudraVigilance activities
- Managing safety case activities, SAEs and ICSRs
- Authoring and reviewing DSURs
- Developing Safety Management Plans and SAE Reconciliation Plans
- Supporting signal detection and benefit-risk activities
- Maintaining PV quality systems and supporting audits and inspections
- Providing leadership, mentoring and oversight to junior colleagues
- Acting as a trusted PV expert for both clients and internal stakeholders
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Essential Experience
- CRO pharmacovigilance background
- Registered Partner (RP) for EudraVigilance
- Strong Argus Safety experience
- Clinical Trial Pharmacovigilance expertise
- DSUR authorship experience
- Safety Management Plan and SAE Reconciliation Plan experience
- Client-facing project management experience
- Strong knowledge of UK, EU and US pharmacovigilance regulations
This is an excellent opportunity to join a growing consultancy environment where you'll have genuine ownership of projects, exposure to international programmes, and the chance to work closely with senior PV leadership and the EEA QPPV.
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