Hays
Pharmacovigilance, Associate Director
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Your new company Are you an experienced Pharmacovigilance professional looking to make a significant impact within a global, research-driven pharmaceutical organisation?
We are partnering with a leading international biopharmaceutical company to recruit an Associate Director Pharmacovigilance on a 12-month contract basis. This is an excellent opportunity for a safety science expert to contribute to the development and lifecycle management of innovative medicines while influencing patient safety strategy at a global level.
Working within a highly collaborative safety organisation, you will provide strategic pharmacovigilance leadership across both clinical development and post-marketing activities, supporting benefit-risk decision-making and ensuring the highest standards of patient safety.
Your new role As Associate Director Pharmacovigilance, you will play a key role within multidisciplinary global teams, providing expert safety oversight across a diverse product portfolio.
Key responsibilities include:
- Providing pharmacovigilance and safety science expertise throughout the product lifecycle, from early development through to marketed products.
- Serving as a core member of product safety and study teams, providing strategic safety input and oversight.
- Leading signal detection, signal evaluation, and signal management activities.
- Conducting benefit-risk assessments and supporting key safety governance decisions.
- Managing post-marketing safety activities and contributing to safety strategy development.
- Authoring, reviewing, and overseeing aggregate safety reports, including: DSURs, PBRERs / PSURs, Safety assessment reports, Regulatory safety responses.
- Providing oversight of individual and aggregate case reporting activities.
- Supporting development and maintenance of: Company Core Data Sheets (CCDS), Investigator's Brochures (IB), Risk Management Plans (RMPs), REMS documentation, Product labelling and safety communications.
- Contributing safety expertise to clinical development programmes and cross-functional project teams.
- Supporting health authority interactions relating to safety and risk management.
- Influencing product safety strategy and contributing to broader clinical development objectives.
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What you'll need to succeed We are keen to hear from experienced Pharmacovigilance professionals with a strong background in safety science within the pharmaceutical, biotechnology, or CRO sector.
You will ideally possess:
- PhD, MSc, PharmD, Medical Degree, or other postgraduate qualification in a Life Sciences or healthcare-related discipline.
- Significant pharmacovigilance and drug safety experience.
- Strong expertise in signal detection, signal management, benefit-risk evaluation, and risk management.
- Proven experience authoring and reviewing DSURs, PBRERs, PSURs, and other aggregate reports.
- A thorough understanding of global PV regulations, ICH guidelines, GVP, and GxP requirements.
- Knowledge of the end-to-end clinical trial lifecycle and post-marketing safety processes.
- Experience working within global cross-functional and matrix environments.
- Excellent analytical skills with the ability to interpret and communicate complex scientific and safety data.
- Strong stakeholder management and presentation skills.
- The ability to work independently, take ownership, and drive safety initiatives with minimal supervision.
- Experience supporting both development and marketed products within a global pharmaceutical environment.
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What you need to do now This is a fantastic opportunity to join a world-class organisation at the forefront of healthcare innovation, working on cutting-edge therapies and contributing directly to patient safety on a global scale.
If you're looking for a high-impact contract role where your safety science expertise will influence key development and post-marketing decisions, we'd love to hear from you.
Click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins on 03330106292
Before you apply for this position, it is vital that you are in possession of a UK passport or relevant visa to work without restrictions in the UK and must be based in the UK.
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