Director, Pharmacovigilance Compliance

At Proclinical, we are seeking a talented and experienced individual to fill the role of Director of Pharmacovigilance Compliance, based in Boston, MA. A senior PV leader and forward thinker, the successful individual will establish and maintain a compliance and PV quality system in accordance with international regulations and guidelines.

Responsibilities

• Establish Metrics and other monitoring systems to measure and verify compliance for senior management.
• Lead PV inspection readiness activities and coordinates for global inspection readiness.
• Maintain and update the PSMF with QPPV and Head of PV.
• Develop and maintain a PV Quality System for Standard Operating Procedures, auditing, CAPAs.
• Assisting in the development, implementation and management of a PV training program.
• Identify solutions to gaps in Pharmacovigilance and monitor completion thereof.
• Develop SMEs and maintain SOPs.
• Develop and maintain Pharmacovigilance Agreements and Safety Data Exchange Agreements. Monitor compliance with required activities according to executed agreements.
• Monitor aggregate/periodic report compliance, reconciliations; monitor quality, timeliness and performance; assist in process.
• Manage EEA QPPV and local QPPV communication, etc.
• Manage training and documentation for PV department and PV training-wide, vendors, etc.

Skills And Qualifications

• BA or higher in related field and 5-10 years of experience in relevant experience. 3+ years of compliance and global PV regulation experience preferred.

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 Yannick Dada at (+1) 6467418433 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.