On behalf of my client a Global Pharmaceutical company, we are recruiting for the role of Pharmacovigilance Company Director. As a member of the global PV management team you will provide leadership in setting the strategic direction of Quality and Compliance PV activities.
This role is suited to candidates who possess strong leadership skills and strategic thinking. Utilizing expert Good Pharmacovigilance (GVP) and Good Clinical Practice (GCP) knowledge this role will be a trusted business partner effectively communicating and collaborating with senior stakeholders and leadership teams across the global organization.
You will be a part of an expert team supporting global clinical development and post-marketing programs.
Active member of the Global R&D Quality & Compliance PV management team
Manage the pharmacovigilance audit program based out of the Dublin, office This includes internal process, affiliate, distributor and external vendor audits
Manage and/or lead diverse & specialized types of audits or projects involving multiple sites, commercial products and/or therapeutic areas.
Effective compliance reporting to senior management and relevant quality governance forums.
Investigate critical compliance Issues
Support CAPA development and perform effectiveness checks of CAPAs
Deliver end-to-end regulatory PV inspection strategy and management, which includes facilitation of regulatory agency PV inspections and partner audits, occurring both in-house and at affiliates.
Support regulatory agency inspections as needed
Evaluate departmental and business area SOPs for fitness for purpose and for compliance with regulatory requirements
Provide Q&C input on new SOPs, often regarding complex processes entailing complicated cross-functional work and inter business partner relationships.
Ensure adherence to departmental SOPs across sites.
Lead intra or interdepartmental teams of an operational nature such as preparing the Company for minor changes in regulations, continuous improvement initiatives.
Direct others in prioritizing their work.
Qualifications & Experience:
BA or BS and 10-12+ years of relevant experience (10+ years of relevant experience with an MS).
Must have significant GVP & GCP audit and compliance experience.
Bio-pharma sponsor or CRO experience required.
Recognized as an expert resource on a range of clinical compliance topics.
Strong verbal and written communication skills and interpersonal skills.
Proficient in Microsoft Office suite. Experience with audit management/CAPA management programs strongly preferred.
Excellent organization skills and project management.
Able to work equally well as part of a team or independently
Ability to travel approximately 25% required.
For more details and confidential discussion please email email@example.com or call Tina at +353 1 2784671. Thornshaw is a leading provider of services for the Pharmaceutical. Life sciences and Medical Device industries. www.thornshaw.com