Primarily responsible for the execution of the Pharmacovigilance (PV) audit program, including scheduling, planning, reporting and resolution of PV audits. Ensuring alignment with RDQA policies and procedures wherever possible and leading the development and implementation of the PVQA quality system. Provision of advice and support on PV and quality topics to business partners to ensure compliance with worldwide PV requirements and expectations.  

Responsibilities:

• Assures quality and compliance in a regulated environment that includes worldwide regulations, country specific and other applicable standards and AbbVie policies and procedures by continuous evaluation of PV processes through audit and QA oversight activities.
• Lead PV audits (internal, affiliate and third parties) to ensure compliance to global regulatory requirements and AbbVie requirements. Effectively communicate audit results, both orally and in writing.
• Assimilates audit observations and compilation of PV audit reports and reviews and approves Corrective Action Plans submitted in response to audit observations within target timeframes. Track actions through to completion.
• Assist in the design, planning and execution of risk-based methodologies to inform the annual PVQA audit plan
• Advances the AbbVie Quality System through contribution to the development and implementation of systems and processes required to support global quality assurance requirements.
• Contributes to development and continuous improvement of necessary PV systems to assure compliance to worldwide regulations and corporate policies.
• Participates in and supports PV inspections onsite or remotely to ensure that PV inspections are a success.
• Promotes continuous education with regards to PV regulations for self and other AbbVie staff. Support team members in their development and training.

• Bachelor’s degree in science (physical, life, health), a health care profession (e.g., nursing or pharmacy) or equivalent experience
• Experience in the biopharmaceutical industry or with a regulatory authority
• Experience in Quality Assurance and/or Pharmacovigilance

An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific experience listed above.

Essential:

• Experience leading PV audits
• Understanding of PV quality systems and auditing standards
• Knowledge of PV regulatory requirements and industry best practices
• Strong analytical skills and the ability to organize work in a logical, thorough, and succinct manner.

Preferable:

• Flexibility to adapt to changing assignments and ability to effectively prioritize.

• Project management, interpersonal, and communication skills and ability to work independently and as part of a team.
• Willingness and ability to perform international travel

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.