Director, Drug Safety & PV Operations job in Massachusetts

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Discipline: Drug Safety / Product Safety

Job type: Permanent

Location: United States

This vacancy has now expired. Please see similar roles below...

At Proclinical, we are seeking a talented individual to fill the role of Head of Drug Safety and Pharmacovigilance Operations (Associate Director/Director), based in Massachusetts. The successful individual will be responsible for the operational management and oversight of internal and external case processing activities, expedited safety reporting and partner data exchange, as well as ensuring compliant ICSR processing.

Responsibilities

Provide expertise on safety operations and overall data quality during audits/inspections.
Maintain and improve a robust oversight plan related to internal and external case processing.
Review and approve governing documents such as SOPs, Operating Guidelines and Safety Management Plans to ensure operational implementation.
Partner with PV Quality, Compliance and Infrastructure in the review of PV vendor metrics reviews; develop and implement CRO case processing vendor improvement plans and evaluate outcomes of implemented improvement plans.
Ensure submission of expedited safety reports and other external submissions through effective vendor management and performance metrics review.
Provide PV operational support to clinical trial study teams; develop and monitor adverse event reporting site performance metrics.
Develop adverse event receipt and processing structure.

Skills And Qualifications

BA in nursing, pharmacy, or healthcare/life sciences related discipline. MA/Doctorate-level degree preferred.
3+ years of drug safety or pharmacovigilance experience.
2+ years of experience working with CROs, vendors and relationship management.
Expert knowledge of FDA and EU legislation and ICH pharmacovigilance guidelines.
Experience with selection and working with contract service providers for case processing, aggregate reporting and quality management activities.
Extensive experience in performance management of PV systems.
Experience with regulatory inspections and company audits.
Strong written, verbal, and interpersonal communication skills.

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 Darren Whyte at (+1) 6465420158 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.

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