Job URL
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Job Details
Job ID: 126
Job Title: Interim Associate Director Pharmacovigilance Quali
Job Type:
Hire Type: Direct Hire
Level: Managerial
Recruiters: Hannah Woodward,Sophie Taylor
City: Harefield
Country England

Job Description
Description: To provide Global Quality Assurance leadership and oversight of global pharmacovigilance & device vigilance systems. Globally responsible to establish a risk-based quality assurance process across the Norgine pharmacovigilance universe.
Requirements/Qualifications: • A scientific degree is essential with demonstrable experience of Pharmacovigilance, some of which should be in PV QA.
• Extensive specialist knowledge of pharmacovigilance and PV QA within the pharmaceutical industry.
• Proven experience in establishment and oversight of Pharmacovigilance QA activities for both clinical trial/development studies and commercial marketed product
• Record of successful preparation and hosting or 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.
Responsibilities: • Develop, manage and oversee a global risk based audit program across the PV universe to ensure effective QA oversight of Norgine PV, and DV activities
• Manage and conduct PV and DV audits of processes, affiliates and third parties
• Partner with business areas through provision of consultancy regarding DV and PV compliance issues
• Plan, conduct and close out or oversee PV & DV audits as required
• Ensure continual compliance with policies, procedures and PV/DV regulations through continual evaluation of PV/DV processes
• 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 inspections and DV aspect of notified body audits
• QA interface for partner audits, responsible to lead preparation for and hosting of partner audits of Norgine PV processes

Accountabilities
The job holder is accountable for:
• Ensuring that a global risk based audit program is established that provides a measure of Norgine compliance with PV and DV regulatory expectations and any gaps are identified and reported to responsible management
• Highlighting and escalating areas of concern and non-compliance with PV and/or DV and proposing remediation to senior management
• Supporting GPV and country personnel responsible for GVP compliance in implementation of appropriate systems and compliance metrics
• Conducting audits in line with PV and DV requirements
• Act as a Norgine PV QA ambassador in interactions with partners, regulatory agencies and industry bodies

KEY COMMITTEE MEMBERSHIPS
• Key member of the PV CAPA task force: responsible secretary
• Development Quality Council (ad hoc member)
• Member of the Global Quality Executive Team


MAIN TASKS

• Act as functional lead for Global PV and Device Vigilance (DV) in line with global Quality objectives
• Responsible for establishment and oversight of appropriate risk based PV and DV audit programs
• Act as expert consultant to the business for compliance related issues including interpretation of global regulations and requirements to support implementation of the Norgine Global Quality strategy for PV QA
• Support notified body and competent authority statutory inspections of DV, and PV, including preparation, facilitation and response support
• Support Global Quality where appropriate through performance of GxP audits
• Lead specific global Quality based projects when required
• Contribute to the Global Quality strategy as a member of the Quality leadership team

RELATIONSHIPS:

• The individual is expected to act within their area of responsibility with limited reference to manager
• The role is expected to be highly proactive in interactions across all Norgine functions that impact PVQA
• The job requires an ability to deal with a high level of technical complexity, excellent problem solving skills and a tolerance for ambiguity
• The role spans all of the global Norgine operations that are subject to PV and DV controls and thus interfaces with many discreet departments
• The individual will have the emotional intelligence and diplomacy to operate effectively at Chief, VP and Director levles senior levels across Norgine and have excellent networking skills to interact across all Norgine functions and business units impacted
• The job requires excellent 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 level 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

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