PW-6763 PV Compliance and Training Manager
Closing Date: 10 Dec 16
Salary (£): Competitive
An opportunity to define compliance culture within the International PV department of a leading global pharma. You will lead and manage PV activities in the EMEA region to ensure compliance with applicable regulations and global SOPs and provide support and direction to EMEA PV managers to identify of training needs and appropriate training plans.
- Leading, innovative global pharmaceutical company
- Hertfordshire based
- EU Headquarters
- Global leadership role
- Line management and mentoring of PV Operations scientists
- Provide support for and co-ordinate regional PV audit and inspection readiness activities; liaise with the regional PV team and corporate PV audit department in the risk assessment of the PV system and development of audit strategy
- Liaise with members of Global Drug Safety and other functions to ensure effective development of CAPAs arising from internal GxP audit findings and/ or EU Competent Authority PV inspections.
- Identify key PV risks and collaborate with Director PV Operations, QPPV and global colleagues to address compliance concerns and support implementation of risk mitigation.
- Develop and implement monitoring programmes to ensure EMEA region PV compliance with regulatory requirements and global/ regional SOPs; oversee the management of deviations and associated CAPAs.
- Contribute to the continuous improvement of the PV quality system, in association with Global Drug Safety, and lead identified EMEA process improvement initiatives.
- Liaise with EMEA PV alliance management and other functions to ensure company compliance with PV Agreement requirements and undertake compliance monitoring as required
QUALIFICATIONS / EXPERIENCE REQUIRED
- The candidate should be a life science graduate or equivalent with significant pharmacovigilance experience, including experience gained at a global level, ideally across a range of pharmacovigilance processes..
- Excellent working knowledge of global PV regulations, including EU, US and ICH requirements.
- Experience of coordinating project/ process improvement initiatives and in leading matrix teams to a successful outcome
- Experience in compliance and quality system management, including development of SOPs and CAPA management is highly desirable
- Possess a strong sense of responsibility and have a good track record of working to deadlines
- Excellent organisation and project management skills
- Good written and oral communication skills
- Ability to work consistently and autonomously, seeking advice where necessary
- Able to form strong cross-functional with individuals from various cultural backgrounds
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.
For a confidential discussion please telephone Christian Simon at AXESS Limited on 020 8560 2300. To apply, please send your CV to firstname.lastname@example.org quoting reference PW-6763.
PV Compliance / PV Manager / Safety Compliance / Risk Mitigation / Risk Management Plans / Training / GPV / CAPA / Process Improvement / permanent / South East / drug safety careers / PV Careers / Pharmacovigilance / Drug Safety / metrics / process excellence / QA / Quality Systems / Quality Systems Management / QMS / Audits / Project Management / Global / EMEA / EU Competent Authority PV inspections / Line Management / Coaching / UK
AXESS has been operating since 1990
We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development
We match professional candidates to the best permanent, contract and interim roles in the market
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