Director, Pharmacovigilance Operations

ProClinical Ltd
13 Nov 2017
15 Nov 2017
Contract Type
Full Time
ProClinical is seeking a Director, Pharmacovigilance Operations for a global pharmaceutical company to be based in Maidenhead on a permanent basis. The Head of Pharmacovigilance & Risk Management (PVRM) Operations is a member of the Global PVRM Leadership Team and is responsible for strategic leadership and the execution and control of ongoing business operations of PVRM. The job holder's purpose is to ensure compliance and enhance the value of PVRM activities through the provision of cost-effective, efficient and high quality PVRM systems, processes, tools, standards and training. The Head should be a Subject Matter Expert (SME) in at least one of these functions.

This position is the point of accountability for the company's global safety database outsourced to two major vendors (respectively responsible for hosting and processing the Individual Case Safety Reports), ensuring compliance with all regulatory requirements.

Job Responsibilities:

* Ensuring that PVRM operates in a business-like manner, providing budget and administrative coordination across PVRM in support of yearly financial planning, forecasting and reporting. Working with Project Management and Finance in preparation of financial reporting for PRC and portfolio reviews of all PVRM programs.

* Establishing and maintaining governance over outsourced vendor relationships and strategy to ensure compliant, high quality, efficient, cost effective and timely operational execution.
* Key point of contact for senior level governance of strategic vendors/CRO partnerships.
* Ensuring all contracts are maintained, updated and understood by relevant Legal and PVRM-responsible individuals so that the Company and its vendors meet their legal obligations.
* Ensuring administrative support for managing PVRM vendors.
* Ensuring ongoing management and support of all PVRM-specific e-clinical systems to support smooth, efficient, cost-effective and timely delivery of relevant information.
* Maintaining and coordinating the revision of Standard Operating Procedures to ensure ongoing compliance and the efficient conduct of PVRM activities.
* Ensuring that company employees are trained in the relevant adverse events reporting process.
* Ensuring compliance to Quality Standards:

* developing and producing the metrics for PVRM.
* defining and implementing PV processes in accordance with international PV legislation including the preparation of corresponding PV Standard Operating Procedures/ Work Instructions and other PV documents.

* Leading inspection preparation activities for the clinical team and serving as primary liaison between PVRM and Clinical Quality Assurance.
* Supporting PV related GVP, GCP and GMP audits & inspections, including follow up activities for corrective and preventive actions (CAPAs) to health authorities and tracking of commitments.
* Recruiting, retaining and developing a high quality, appropriately qualified team.
* Ensuring accountable performance management of all staff against work plans and expected behaviours.
* Coordinating and facilitating the smooth engagement of Clinical Shared Services staff and activities within PVRM and wider company (including but not limited to Finance, Legal, IT, Project Management, Regulatory Affairs, Technical Development and Technical Operations).

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Kevin Hansberry on Phone number removed or upload your CV on our website - URL removed
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.