Job Description
The Director of Pharmacovigilance Operations is responsible for overseeing the delivery of Global Patient Safety Department services in compliance with ICH-GCP guidelines, regulatory requirements, and standard operating procedures.
This role involves managing processes and systems that enable the initial intake of adverse event data, subsequent reporting of Individual Case Safety Reports to health authorities, Alliance Partners, and internal destinations. The position also requires oversight of all aspects of Intake and ICSR submissions, including vendor management.
A key responsibility of this role is to ensure receipt of complete and accurate safety information, which involves leading a global team responsible for all aspects of Intake and ICSR submissions across the company's product portfolio. This includes pre- and post-marketing activities.
Additionally, the Director will be responsible for maintaining all reporting rules in the global safety database, Argus. A typical day may involve tasks such as expert knowledge of tools and systems for data automation, advanced data validation, and analytics. Other responsibilities include the oversight of vendors and the assessment of study particulars and reporting requirements across current global regulations.