215 First Street
Job Category: Clinical: Pharmacovigilance (PV)/Drug Safety
Job Number: 1989
This position serves the primary focus of creating the global Pharmacovigilance (PV) department and will be responsible for the PV Operations activities globally across all products in clinical development and on the market. The incumbent will be joining the growing PV department and be an integral member of the PV leadership team reporting directly to the Vice President and Head of PV.
Responsibilities 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. This person needs to be highly motivated and is expected to provide innovative, critical, and strategic input and leadership.
- 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. as needed.
- 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.
- Liaise with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Manufacturing, and Legal.
- Support the Head of Pharmacovigilance develop and implement appropriate drug safety programs and processes
- Healthcare degree in nursing or pharmacy
- Minimum 10 years’ experience in PV operations
- Ability to build relationships and influence across disciplines and all levels
- Global experience is required.
- Occasional travel 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