Pharmacovigilance Business Process Leader

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Job description

* Pharmacovigilance Business Process Leader - Top Pharma - 12-month contract - OUTSIDE IR35*

My client is a Global Biopharmaceutical company and they have a position available for a Pharmacovigilance Business Process Leader within their Pharmacovigilance team for an initial 12- month contract.

This contract is OUTSIDE of IR35. This contract is REMOTE, based within the UK. Some International Travel maybe required.

Within this role the Pharmacovigilance Business Process Leader will provide principal subject matter expertise for the design, development, maintenance & support of core Pharmacovigilance processes. This is a key enabling and strategic role, ensuring continuing delivery of effective scientific safety activities and\/or PV system activities, in line with regulatory authority and internal stakeholder requirements. You will have a sound understanding of the key aspects of the internal and external environment that relate to core PV processes and will collaborate closely with senior stakeholders across the business, including Global Process Owners and Business Process Owners, the QPPV and members of product- and process-related working groups and governance bodies. This is an influential role in continuous improvement and ongoing process innovation in the safety arena.

In order to apply for the Pharmacovigilance Process Leader contract, you should possess:

* MD or a degree in a life science or healthcare-related discipline (e.g. PharmD, nursing, dentistry, etc.).
* Significant experience in pharmacovigilance and\/or a clinical safety-related role
* Demonstrable 'hands on' experience of delivering or managing safety and pharmacovigilance activities
* A broad understanding of pharmaceutical drug development
* Good knowledge of regulatory pharmacovigilance requirements and guidelines published by the major global Health Authorities (e.g. FDA, EMA, MHRA, etc).
* A general understanding of pharmacoepidemiology and its potential application to safety related activities
* Prior experience in project management and\/or business improvement
* Awareness of 'benefits realization' approaches and change management activities that can ensure process improvements are sustained & measured.
* Ability to operate effectively in, and lead as needed, multi-functional matrix teams
* Excellent written and verbal communication skills (must be fluent in English) and the ability to present and critically discuss clinical data in relation to its significance and impact on the core safety processes in both internal and external discussions.
* Organized, self-motivated and flexible.
* Attention to detail but also able to prioritize and plan activities in line with both personal and wider business priorities.
* Proficient IT skills with the ability to use relevant software\/systems applicable to the role (e.g. MS Office applications, Google applications, dedicated safety or clinical IT systems, etc)
* Able to manage budgets and ability to manage external vendors

Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the UK.

To apply for this position or if you want to discuss other roles that we are working on, please do not hesitate to contact Roberta Atkins on .