Job SummaryGlobal Vigilance lead, responsible for leading and managing the Vigilance group within the US Vigilance Competence Center, including but not limited to global data exchange with Fresenius Kabi entities and other Fresenius Kabi USA partners, adverse drug event reporting, signal management and product quality risk assessments. Ensures compliance with domestic and global pharmacovigilance regulations. Responsible for daily activities of the US Vigilance Competence Center and coordinating activities with all Vigilance Competence Centers worldwide. Leading member of the harmonization team for global compliance.Responsibilities
- Deputy Head of the Global Vigilance Competence Center US (VCC LZ). Contributes to and responsible for implementation of Global Vigilance policies and procedures. May assist the head of the VCC LZ with global functions including Label Working Group (LWG) Coordination, pharmacovigilance document archive coordination, and all quality functions of the VCC LZ. These responsibilities are backed up by the head of the VCC LZ, and the second deputy head.
- Upon nomination, assumes the responsibilities of the deputy National Safety Officer (NSO), assuring the establishment and maintenance of a local PV system within the US Market Unit. This responsibility is backed up by the second deputy NSO and the NSO.
- US Vigilance Operations head, providing leadership, accountability, and guidance for all activities.
- Responsible for managing the receipt, processing, medical assessment, and investigation of adverse drug events in compliance with global and local SOPs, and FDA regulations, guidelines and time lines, ensuring the highest quality of case reports.
- Leading member of harmonization activities within Fresenius Kabi Global Vigilance to ensure that all standard practices and processes are aligned with global counterparts, and all global processes are in alignment with FDA regulations.
- Monitors the performance of the Vigilance team, and maintains local and global KPIs.
- Leads a team of Drug Safety Scientists and Pharmacovigilance Data Entry personnel in all aspects of adverse drug event processing and reporting.
- Responsible for managing the preparation, review, and submission of Periodic Adverse Drug Event Reports (PADER), Periodic Safety Update Reports (PSUR), and expedited, as well as non-expedited case reports. Serves as an Adverse Drug Event (ADE), pharmacovigilance expert, and MedDRA coding expert.
- Leads the Identification, compilation and resolution of quality review findings for the Vigilance team. Verifies completion of case corrections and independently identifies trends.
- Completes root cause analysis of critical quality investigations related to adverse events.
- Reviews and approves adverse event information entered into gCMW.
- Trains and mentors staff locally and globally regarding current knowledge of applicable local and global regulations, standard operating procedures, and guidelines. Monitors pertinent regulatory safety publications, requirements, and guidelines on adverse drug event reporting for potential impact on the department, and the Global Vigilance team.
- Identifies potential drug safety signals in the ARISg database. Reviews adverse drug event data and responsible for preparation of reports for team meetings. Member of the Global Signal Management committee.
- Identifies potential health hazard signals. Notifies the VP of Vigilance and acts as a liaison with the Quality and Regulatory Departments to resolve safety and quality issues.
- May coordinate the provision of Health Hazard Evaluations within local and regulatory time lines.
- Responsible for writing and/or review of all applicable Standard Operating Procedures (SOP's).
- Maintains a courteous, cheerful, and cooperative demeanor at all times, with both internal and external customers.
- Additional tasks and responsibilities as required.
- Bachelors degree required. Medical/clinical professional degree (PharmD, RPh, RN degree) strongly preferred. Advanced degree (PharmD, MSN, or MBA) preferred.
- 7+ years experience in the pharmaceutical industry, in a drug safety or pharmacovigilance department required.
- 5+ years of management experience or experience leading successful teams is required.
- 5+ years of hospital clinical experience preferred.
- Global experience is required.
- Experience with adverse drug event software is required. Knowledge of the ARISglobal database is a plus.
- Experience with preparation of adverse event Periodic Adverse Drug Event Reports (PADER), Periodic Safety Update Reports (PSUR), and expedited reports preferred.
- Ability to understand and interpret federal regulations and company operating procedures as they apply to medically complex adverse drug events and determine whether the events suggest a potential product quality issue.
- Ability to interpret large amounts of safety and quality-related data and recognize/identify potential health hazards (signal detection).
- Must be able to prioritize and multi-task with minimal supervision.
- Excellent written and verbal communication skills required.
- Knowledge of PC systems and Microsoft Office Suite (Word, Excel) is required.
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disabilities, or protected veteran status.