Associate Director/Director, Pharmacovigilance Operations

At Proclinical, we are seeking a talented individual to fill the role of Associate Director/Director, Pharmacovigilance Operations, based in Boson, MA. The successful individual will serve as the primary focus of creating the global Pharmacovigilance (PV) department and will be responsible for all operational PV activities globally. Additionally, responsibilities will include a strategic and tactical approach to management and oversight of the company's PV Operations processes for both investigational and marketed products in compliance with internal SOPs and applicable global regulations and guidelines.

Responsibilities

• Manage the PV Operations function.
• Organize and oversee the receipt, evaluation, processing, documentation and reporting of adverse event information from clinical trials, investigator sponsored trials, post-marketing, etc. sources.
• Manage and oversee PV vendor. Monitor performance and compliance.
• Support ongoing safety surveillance of company products.
• Contribute to regulatory submissions, aggregate reports, investigator communications, labeling, etc.
• Develop and implement PV training programs for internal and external needs and monitor compliance.
• Provide safety and pharmacovigilance expertise in-house for products in development and marketed products.
• Oversee preparation and quality control activities for safety case processing activities performed internally and by vendors or contractors.
• Lead development of standard operating procedures for safety and internal compliance.
• Manage license partners, vendors, etc. with PV Agreements and Safety Data Exchange Agreements.

Skills And qualifications

• BA in related field required.
• Global experience is required.
• Thorough knowledge and understanding of global regulations for safety and pharmacovigilance including FDA, EMA and ICH guidelines.
• Knowledge of MedDRA, WHO DD.
• Experience with Argus and ArisG.
• Occasional travel required.

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.