PV Audit Manager
PV Audit Manager
Reporting to; Associate Director, Pharmacovigilance Quality Assurance
Location; Any Norgine location
Tenure; Full-time, permanent
To provide QA leadership and oversight for PV and pharmacovigilance audit activities, including the establishment and maintenance of a risk-based audit strategy; oversight of any contracted audits; and reporting on the PV and device vigilance risks, trends and effectiveness of the systems within the pharmacovigilance universe at Norgine.
KEY RESPONSIBILITIES & ACCOUNTABILITIES:
- Accountable to deliver the global risk based audit program to ensure effective QA oversight of Norgine PV activities, internally and externally
- Oversee and provide feedback to PV auditors to discuss findings, emerging risks and identify actions to address identified risks, ensuring formal feedback is provided to senior management on a regular basis
- Identify applications of PV QA regulations guidance and laws to existing methodologies to complex problems
- Interpret PV impacting issues and recommend solutions/ best practices to continual compliance with policies and procedures
- Participate in the development and implementation of systems and processes required to support global audit processes and quality assurance requirements
- Participate in and support PV client audits, PV Regulatory inspections and device vigilance aspects of notified body audits on behalf of all Norgine legal entities
- Plan and conduct PV audits of affiliates, partners and systems in line with the PV audit strategy
- Serves as a PV QA expert within the business, proving advice and guidance to the organisation and partners
- The role spans all of the global Norgine operations that are subject to PV controls and thus interfaces with many discreet functions, departments and sites
- As PV auditor, the individual will have close interactions with partners, contractors and varied functions within and external to Norgine
- The job requires a good understanding of PV and DV requirements that are outside of Norgine direct control and the ability to apply these within the Norgine business and ensure clear measure of levels of compliance are reported to Senior Management
- The position will interact with and make reports to VP and Director levels across the organisation
- The individual will need to influence GVP, medical, therapy area and commercial personnel in a constructive way to support the Quality strategy
- The ability to influence and challenge others in a constructive way so as to deliver improvements will be key
- The role is expected to be highly proactive in interactions across all Norgine functions and with external organisations that impact PVQA
SKILLS & KNOWLEDGE
- A scientific degree is essential with demonstrable years relevant experience of Pharmacovigilance, of which a significant amount should be in PV QA.
- Specialist knowledge of pharmacovigilance and PV QA within the pharmaceutical industry.
- Proven experience in over-sight of Pharmacovigilance QA activities for commercial marketed product
- Experience supporting partner audits and competent authority PV inspections
- Strong analytical skills with highly developed quality system knowledge
- Excellent influencing skills and ability to establish effective working relationships with personnel at all levels within Norgine and suppliers
- Proven experience in auditing a wide range of GVP processes and suppliers
- Medical Device Vigilance experience is desirable
- Excellent verbal and written communication skills ability to present effectively to groups
- Able to make data driven recommendation/decisions and take appropriate action.
- Ability to present effectively to groups.Norgine is a leading European specialist pharmaceutical company with a direct commercial presence in all major European markets. In 2017, Norgine’s total net sales were EUR 345 million, up 17 per cent.Norgine employs over 1,000 people across its commercial, development and manufacturing operations and manages all aspects of product development, production, marketing, sale and supply.
Norgine specialises in gastroenterology, hepatology, cancer and supportive care.
Norgine is headquartered in the Netherlands. Norgine owns a R&D site in Hengoed, Wales and two manufacturing sites in Hengoed, Wales and Dreux, France.
For more information, please visit www.norgine.com
In 2012, Norgine established a complementary business Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit www.norgineventures.com.
NORGINE and the sail logo are trademarks of the Norgine group of companies.
Please note that we do try to provide specific feedback to all applications, however sometimes due to the volume of applications received we can respond only to those candidates who best match the position requirements.