30% Execution of Pharmacovigilance System Audit Plan
Provides oversight and leadership to the identification, preparation, conduct and reporting of all audits (includes but is not limited to internal systems/processes, vendors, licensing/distribution partners and Local Operating Companies). in US, Canada and Latin America across all pharmacovigilance related activities within R&D (including touch points with Commercial and Technical Operations corporate functions) governed by Good Pharmacovigilance Practice (GVP), and applicable international and national regulations and guidance. Includes responsibility for the peer review of all US, Canada and Latin America audit reports. Ensures timely closure of audit reports and effective CAPA responses..
30% Compliance Support
Provides support to key stakeholders in an advisory/consultative capacity in compliance related safety matters including issue identification, risk assessment, impact assessment, investigation and driving agreement with stakeholders on corrective and preventive actions. Works collaboratively with other R&D QA&C functional areas to ensure effective communication of issues that impact on other quality areas. Reviews and assesses metrics in collaboration with the Quality Operations group to ensure trends are routinely communicated to senior leadership teams for continuous improvement purposes.
20% Regulatory Agency Support
This position will be expected to contribute to leadership of SME teams in the preparation, hosting and follow-up of pharmacovigilance related regulatory agency inspections conducted in US, Canada and Latin America.
As a senior member of the Safety & International team, coaches team members as required as part of onboarding and development of the overall team and contributes to development and conduct of team meetings and workshops.
10% R&D QA & Compliance Leadership initiatives
As a senior member of the R&D QA&C team, lead R&D QA&C compliance initiatives under the direction of the Leadership team and contribute to Departmental Meetings. Education and Experience Requirements
Bachelor's degree in a life science required; Masters Degree in management or scientific discipline a plus.
Other Job Requirements
- At least 10 years of pharmaceutical experience.
- Ideal candidate will have broad experience in pharmacovigilance, regulatory compliance and preferably experience in GVP auditing.
- Demonstrable leadership skills ( line management, project management,)
Domestic and international travel required to locations where Pharmacovigilance audits and/or Regulatory Agency Inspections are conducted. Must have a global mindset.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.