Job Description

:

• This position reports to the Director, Global PV Quality Assurance and frequently interacts with cross-functional teams.
• This role is a member of the GVP QA team providing Quality oversight of global post-marketing pharmacovigilance system, including clinical safety, full application of EMA Good Pharmacovigilance Practices (GVP) Modules, and implementation of other worldwide PV regulations.
• This includes support for the development and execution of the GVP audit program as well as contributing to the companies Inspection activities.

Responsibilities:

• Senior Manager, PV QA supports all the GVP QA's responsibilities as listed below. Different members of the team will have particular focus areas. Senior Manager will lead specific activities.
• Serve as a strong partner with Expertise Areas (EAs) in the enhancement of the global pharmacovigilance system, including ensuring compliance with GVP regulations. This includes review of procedural documents.
• Partner and support EAs in ensuring conduct of non-interventional, observational, and post-marketing surveillance (PMS) meet regulatory requirements and expectations considering Good Pharmacoepidemiology Practice (GPP) and Good Post-marketing Study Practice (GPSP).
• Support cross GxP QA activities requiring PV and PMS expertise.
• Execute on global core auditing processes for licensing partners, external vendors, internal audits, affiliates, and other applicable service providers in a post-marketing environment.
• Determine, evaluate and investigate Quality Events. Determine adequacy of root cause analyses and CAPAs. Applies risk-based thinking in determining required actions.
• Effectively communicate and escalate critical matters to management.
• Support the Global Strategic Audit Program - contribute to risk-based audit strategy and maintain and enhance PV audit universe, risk tools and develop PV audit schedule.
• Provide QA Audit, CAPA and Supplier data for the PV System Master File (PSMF). Develop and maintain efficient processes to ensure comprehensive and accurate data.
• Develop and maintain processes and tools to support quality audit execution and outcomes.
• Support PV / post-marketing surveillance inspection readiness and inspection management activities.
• Provide Quality oversight of PV, PMS and PV-related vendors. This includes vendor notification, qualification assessments, Quality Agreements, KQIs and audits.
• Develop and report GVP QA metrics and dashboards to support quality oversight.
• Develop and maintain GVP QA Training Plan; conduct PV and PMS training sessions for QA and EAs.
• Lead or contribute to Quality or PV and PMS initiatives. Identify and propose process improvement opportunities and solutions.
• Other assignments as directed.

Requirements:

• Educated to university degree (preferably life sciences) or equivalent qualification or experience.
• Extensive experience in the pharmaceutical industry in a quality or compliance function.
• Audit skills and experience of conducting GVP audits is preferred.
• Understanding of and working experience with international GVP regulations, FDA PV requirements, Health Authority guidance and ICH.
• Experience supporting Health Agency inspections.
• Self-motivated with the ability to demonstrate initiative and internal drive for continuous improvement.
• Strong interpersonal, verbal, and written communication skills. Builds positive and productive working relationships.
• Diplomatic in addressing sensitive issues confidentially and professionally. Works professionally with confidential information.
• Ability to analyse complex situations / issues. Demonstrates strategic thinking

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