Associate Director, Pharmacovigilance QA - Oxford, Oxfordshire, United Kingdom - Jazz Pharmaceuticals

Description

If you are a Jazz employee please apply via the Internal Career site

Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases - often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines and novel product candidates, from early- to late-stage development, in neuroscience and oncology. We actively explore new options for patients including novel compounds, small molecules and biologics, and through cannabinoid science and innovative delivery technologies. Jazz is headquartered in Dublin, Ireland and has employees around the globe, serving patients in nearly 75 countries. For more information, please visit and follow @JazzPharma on Twitter.

Brief Description:

• To lead Jazz's Pharmacovigilance QA (GvP) function to assure regulatory compliance and data integrity in all Jazz activities related to Pharmacovigilance.

Essential Functions

• In collaboration with the Sr Dir, Clinical & PV QA, ensures the implementation of the Global Quality strategy, as relevant to pharmacovigilance (PV) QA.
• Supports implementation of Jazz's Quality Management System (QMS) as it applies to PV QA activities
• Verifies that data integrity principles are adhered to within Jazz's PV activities
• Manages the process to verify, through risk-based independent audit, compliance of PV activities with national/international regulations and guidelines on Good Pharmacovigilance Practice (GvP) and applicable Jazz SOPs
• Assesses and escalates to line management, the risk of any critical or major audit finding identified through audit activities
• Promotes GvP awareness amongst Jazz personnel and develops and maintains Jazz's GvP standards through the provision of training, review, advice and guidance services.
• To actively monitor the compliance status of PV at Jazz through the maintenance of leading and lagging metrics; to communicate this compliance posture to line management, including participation in the R&D-QMR.
• Interprets, communicates and implements changes in GvP, ICH and other compliance related regulations, standards and practices, as related to PV
• Manages and supports activities for Jazz related to GvP inspection readiness for inspections conducted by national and international regulatory authorities and other external bodies, such as marketing partners. Acts as an inspection lead/host.
• In collaboration with the head of PV Compliance, leads projects to deliver improvements in productivity and efficiency in all areas relevant to pharmacovigilance, including leverage of Jazz Remix
• Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks and participating in professional societies.
• Works within the assigned budget for the Clinical & PV Quality group
• Operates in accordance with the Jazz corporate values
• To build collaborative relationships with key internal and external stakeholders.
• Leads or participates in other projects, indirectly related or unrelated to the above listed accountabilities, as assigned by line manager/Global Head of Quality

Required Knowledge, Skills, and Abilities

• Excellent organizational, verbal communication and presentation skills.
• Effectively leads and participates in multi-disciplinary teams.
• Skilled at developing his/her team to reach their full potential, both individually and collectively.
• Makes good decisions, based on a mixture of analysis, wisdom, experience, and judgement.
• Works independently, with minimal direction.
• Assertive, proven leader with a strong results orientation and sense of urgency.
• Knowledgeable of FDA/EMA/MHRA and other relevant regulatory requirements applicable to PV; applies this knowledge to all aspects of the position.

Required/Preferred Education and Licenses

• Bachelor's degree in life sciences or a related discipline. Post-graduate qualifications preferred (especially in Quality Management, PV, or related field).
• 12+ years in pharmaceutical industry, including a minimum of 5 years in a leadership position within the bio/pharmaceutical industry.
• Prior experience of working in bio/pharmaceutical R&D.
• Extensive experience in GvP regulatory compliance requirements, with the ability to apply this knowledge to resolve day-to-day issues

Jazz Pharmaceuticals is an Equal Opportunity Employer.