Director Pharmacovigilance Compliance

At ProClincial, we are seeking a talented individual to fill the role of Medical Director, Head of Medical Review, based in Cambridge, MA. The successful candidate will become a vital contributor to the global compliance team.

Responsibilities

• Ensure the compliance activities related to PV inspection/audit readiness for Global PV, coordinating with the US, EU and Japan Compliance leads and partnering with QA to determine internal PV audit areas of focus.
• Ensure the oversight of the coordination of pharmacovigilance activities and deliverables during inspections and audits.
• Develop and propose recommendations based on findings from external and internal inspections and audits worldwide to focus GPSE global Compliance more towards preventive actions to sustain our culture of "zero tolerance for late cases" (except for Japan and EU/EEA territories).
• Ensure timely audit and inspection responses for the PV function and appropriate ownership of corrective and preventative action plans (CAPAs) by PV subject matter experts (SMEs) worldwide (except for Japan and EU territories).
• Collaborating with the Global PV functions to ensure compliance tracking processes and inspections and audit procedures/processes are in place that reflect alignment with various regulatory authorities' regulations worldwide
• Ensure that adequate processes are in place to maintain current knowledge of and adherence to Compliance and relevant PV regulations, including evolving changes in the regulations that may impact compliance.
• Lead the development of PV compliance programs and quality tools.
• Design and implement appropriate mechanisms for maintaining and communicating compliance information across GPSE departments and R&D.
• Collaborate all relevant functions in the development and management of CAPA.
• Direct and manage execution of compliance activities.
• Develop and implement PV systems.
• Collaborate with the GPSE Training group in the development of training strategies to ensure that GPSE processes meet PV compliance regulatory requirements worldwide.

Skills And Qualifications

• BA in related required (advanced degree preferred) and 10+ years of relevant experience.
• Experience in global PV environment with additional demonstrable experience in leading support of pharmacovigilance and/or GCP audits/inspections
• In depth knowledge and comprehension of global pharmacovigilance regulations, compliance practices and ability to interpret multiple requirements into concise clear instructions.
• Familiarity with inspections and audit procedures
• Knowledge of compliance international Regulations and ICH environment foundations
• Strong computer literacy.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Anna Graham at (+1) 6465420152 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.