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.
Education
•Bachelor's degree in Life Sciences, Pharmacy, Medicine or a related discipline
•Additional qualifications in Quality Assurance, Pharmacovigilance, or GVP compliance are considered an advantage
Experience
•At least 10 years of proven experience in Pharmacovigilance
•At least 5 years of proven experience in GVP auditing
•Demonstrated experience in planning, conducting, documenting, and following up audits
•Experience working in regulated environments within the pharmaceutical industry
•Exposure to global or multi-country pharmacovigilance activities
Technical Skills
•Strong knowledge of global and local pharmacovigilance regulations, guidelines, and Good Pharmacovigilance Practices (GVP)
•Solid understanding of core pharmacovigilance processes
•Ability to assess compliance with regulatory requirements, internal procedures, and quality standards
•Strong analytical skills with the ability to identify compliance gaps, assess risk, and recommend corrective and preventive actions
•Excellent documentation and audit report writing skills
•Fluency in English required; 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 of attention to detail, integrity, discretion, and confidentiality
•Ability to work independently, manage priorities, and meet deadlines
Additional Requirements
Availability to travel at least 30% of the time.
Full time position.
Affiliated Companies: PharmaLex Spain S.L.U.
