Senior Manager, Regulatory Compliance (Pharmacovigilance)
12 month Contract
Our client is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. They are currently looking to hire a contractor on a 12-month basis. Reporting to the Director of Compliance, you will be responsible for leading the pharmacovigilance audit programme, including internal process audits and external vendor audits and you will coordinate audit follow-up and corrective action planning.
* Maintaining knowledge of pharmacovigilance regulations and company standard operating procedures for pharmacovigilance
* Ensuring the completion of pharmacovigilance annual audit plans
* Establishing excellent working relationships with stakeholders in assigned departments and compliance/quality groups of vendors or business partners
* Providing guidance on interpretation and application of existing and new regulatory requirements to Regulatory Compliance management and assigned departments
* Assisting with the provision of guidance and training to Regulatory Compliance, developing standard training modules on special topics
* Assisting in the evaluation of SOPs and processes needed to comply with regulatory requirements
* Providing guidance to assigned departments and management when specific compliance issues arise
* Assisting with the preparation, facilitation and follow-up of regulatory authority inspections
* You will foster a commitment to quality in individuals and a culture of quality within the organisation
* Carrying out work with little to no immediate supervision
* Evaluating new tools as fit for purpose, they will coordinate and review the work of others
* Managing, leading or participating in various types of audits or projects involving multiple sites
* Establishing relationships and agreements with consultant auditors
* Directing and collaborating with internal and external staff in the conduction of audits
* Leading and participating in intra- or interdepartmental teams of an operational nature such as: preparing the Company for changes in regulations, continuous improvement initiatives etc.
* Initiating operational change where required and communicate change in a positive manner
From time to time you will be expected to assist with activities for other GxP compliance programmes, and as such you will be required to develop knowledge in these areas.
Apply for this Senior Manager, Compliance opportunity now via this website, or call Will on 01628 581 240!
Star is a full service resourcing and outsourcing company which resources at all levels for pharmaceutical, medical devices and technology, clinical research and healthcare communications companies in the UK and Ireland on a headcount and outsourced basis. If you haven't heard from us within 7 working days of submitting your application, please assume that you haven't been successful on this occasion. We wish you the best of luck with your job search.