Regulatory Affairs Pharmacovigilance Senior Analyst

Nature and scope: This position is responsible and accountable for all aspects related to the handling and submission of safety information for all ARI products to the FDA. This will include post-marketing data, clinical trials, literature and any other sources. Essential duties and Responsibilities

• Performs prospective and retrospective QC of cases to ensure individual case study report ICSR quality and monitors that all cases move through the workflow steps to ensure compliance with regulatory timeframes.
• Supports the team on safety-related issues and responsible for submission of clinical regulatory responses, PADERS, POC, Vet and Human case submissions, study protocols, IBs, CRFs, reports and other documents to the FDA and other health authorities as required.
• Collaborates with clinical development, medical affairs, PV leads and Regulatory Affairs to monitor the processing, submission and tracking of expedited safety reports to appropriate domestic and international regulatory authorities.
• Collaborates with AR Pharmacovigilance team on effective processes with 3rd parties for any outsourced activities
• Manage and ensure quality documentation of safety data, particularly serious adverse events (SAEs), through direct contribution in a matrix environment.
• Supports maintenance and archival of manual and electronic drug safety files pertaining to ICSR management.
• Develop and maintain proper SOPs for regulatory submissions of safety reports and documents.
• Review current processes within PV and RA to determine if updates or process improvements can be made.
• Oversight on third party processing and SAE reconciliation activities
• Train and mentor staff as needed on PV related submissions to FDA and other health authorities.
• Prepare and lead/support the conduct of PV audits and regulatory inspections
• Perform any other tasks/duties as assigned by management.
• We all must embrace the QUALITY culture.

Qualifications and Requirements

• Bachelor’s degree in a life science or higher nursing, pharmacy or related health care filed required.
• Minimum of 7+ years in pharmacovigilance operations or health science experience.
• Good understanding of drug safety requirements and health authority regulations for adverse event reporting, and working knowledge of the importance of regulatory compliance
• Experience working with drug safety database.
• Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision.
• Strong organizational, interpersonal and communication skills (oral and written).

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status. American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact Ada Palatnik, Talent Acquisition, Lead Specialist at 631-438-6371 or email at apalatnik@americanregent.com.