PHARMACOVIGILANCE AUDITOR

Cencora, Inc.; United States; À distance; USD 120 000 - 180 000; Plein temps

Résumé du poste

Cencora, Inc. is seeking a senior Pharmacovigilance Auditor to lead and execute PV audits for diverse clients worldwide. You will coordinate GVP audits, support mock inspections, assess PV systems and drive improvements in regulatory compliance.

The role requires extensive PV experience, strong audit and communication skills, and willingness to travel 30% of the time to support multi-country activities.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Medicine or a related discipline.
• Additional QA, Pharmacovigilance or GVP qualifications are advantageous.

Responsabilités

• Lead and provide pharmacovigilance expertise to clients in PV audits.
• Coordinate and perform GVP audits as lead or co-auditor.
• Support mock inspections and Health Authority interactions.
• Assess PV systems, processes and interfaces for compliance.
• Manage CAPA and ensure continuous improvement of PV programs.
• Advise clients on GVP and legislation compliance.
• Design audit strategies, risk assessments and audit programs.

Connaissances

Pharmacovigilance

GVP auditing

Audit planning

Regulatory compliance

Quality assurance

Stakeholder communication

Formation

Bachelor's in Life Sciences / Pharmacy / Medicine

QA / Pharmacovigilance / GVP qualifications

Description du poste

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

Responsibilities:

Professional leadership and provision of pharmaceutical expertise to clients across the field of pharmacovigilance:

• Responsible for the execution of operational tasks and all aspects of technical delivery and project management in the field of PV Audits.
• Coordinating and performing GVP audits as lead- or co-auditor (process-, system- and document audits).
• Mock inspections and assistance to pharmaceutical companies during Health Authority inspections.
• Pharmacovigilance service provider audits.
• Assessment of pharmacovigilance systems and processes including interfaces with other departments, affiliates or contract partners of clients.
• Management of corrective/preventive action plans.
• Acting as an external consultant for assessment, quality assurance and improvement of pharmacovigilance systems and processes.
• Review and set-up of QM requirements related to PV-System set-up or maintenance.
• Providing advice to clients regarding Good Pharmacovigilance Practices and legislation compliance.
• Design and preparation of audit strategy, risk assessment and audit programs.

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Education

• Bachelor’s degree inLife Sciences, Pharmacy, Medicine or a related discipline
• Additional qualifications inQuality Assurance, Pharmacovigilance, or GVP complianceare considered an advantage

Experience

• At least 10 years of proven experience inPharmacovigilance
• At least 5 years of proven experience inGVP auditing
• Demonstrated experience inplanning, conducting, documenting, and following up audits
• Experience working inregulated environmentswithin the pharmaceutical industry
• Exposure toglobal or multi-country pharmacovigilance activities

Technical Skills

• Strong knowledge ofglobal and local pharmacovigilance regulations, guidelines, andGood Pharmacovigilance Practices (GVP)
• Solid understanding of core pharmacovigilance processes,
• Ability to assess compliance withregulatory requirements, internal procedures, and quality standards
• Strong analytical skills with the ability to identify compliance gaps, assess risk, and recommend corrective and preventive actions
• Excellentdocumentation and audit report writing skills
• Fluency in Englishrequired; additional languages are an asset

Soft Skills

• Strong communication and interpersonal skills, with the ability to engage effectively with stakeholders at different levels
• Ability to conduct interviews and communicate audit findings in a clear and professional manner
• High level ofattention to detail, integrity, discretion, and confidentiality
• Ability to workindependently, manage priorities, and meet deadlines

Additional Requirements

Availability to travel at least 30% of the time

What Cencora offers

Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Full time

Affiliated Companies

Affiliated Companies: PharmaLex Spain S.L.U.

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [e-mail]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned