Description:

Reporting directly to the Chief Quality Officer, the Vice President, Pharmacovigilance is responsible for providing business strategies that support FDA compliant Call Center and Safety data management systems in order to address and resolve all Medical Inquiries, Customer Complaints and Adverse Event reports for US and ex US products for which Amneal is the approved application holder, as well as for products distributed by Amneal for which SDEAs exist. He/ She provides strategic development, overall management, and leadership to assure that all activities carried out by the Drug Safety Call center and Pharmacovigilance Team are in compliance. He / She will also serve as the company pharmacovigilance expert, working in partnership with Medical Affairs and Clinical Affairs teams to bring important drug safety issues to the attention of Executive Leadership. This role will have risk management and compliance oversite, particularly as it relates to oversight of the REMS (Risk Evaluation and Mitigation Strategies) program which includes qualitative and quantitative reviews to ensure ongoing compliance. As leader of the PV function, he / she will have oversight of the enterprise systems, databases, and automation tools (e.g., AI) that support pharmacovigilance.

Essential Functions:

Responsible for overall leadership of sustaining a leading‐edge, high quality global Pharmacovigilance team operating within the complex global regulatory-pharmacovigilance environment while providing strategic leadership for the Global Patient Safety team in all aspects of pharmacovigilance including oversight for those providing; intake and triage of all cases from the intake call centers, triage of quality complaints; case processing of adverse events and medical inquiries, production of post marketing surveillance aggregate reports for drugs and Medical Device Reports for combination products, and all safety related queries. Provides coaching and mentoring to PV staff to ensure appropriate levels of accountability for delivering according to Amneal’s standards of compliance. Establishes appropriate governance, systems, and processes to: identify and evaluate safety signals through the assessment of single case safety reports and aggregate safety report trends; support development and maintenance of product risk-benefit profiles; and identify opportunities to investigate and lead change through innovation and continuous improvement in drug safety surveillance. Provides health hazard assessments for quality related issues. Reviews safety related sections of clinical protocols and addresses potential safety issues during clinical study conduct. Manages resources to ensure that approvals are timely and development objectives are met including workforce planning and resource allocation decisions for department. Holds leaders accountable to deliver department objectives within budget. Collaborates with Global Patient Safety colleagues from partnership companies to develop compliant Safety Data Exchange Agreements. Represents Amneal at the highest level with Governmental, Regulatory and various Health Authorities. Manage PV mock audit to ensure compliance, prepare for regulatory inspections, respond to regulatory inspection findings, ensure to implement effective CAPA.