The Specialist III, Global Safety will support safety and pharmacovigilance activities, collaborate with safety physicians, conduct safety surveillance, and support risk management activities for clinical trial and postmarketing products.
Serve as product safety expert and perform pharmacovigilance and safety surveillance responsibilities, including interpretation and evaluation of individual and aggregate adverse event and product complaint data for signal detection, trend analysis, and issue investigations for clinical trial program.
Conduct proactive and comprehensive safety assessment in supporting safety profile for respective compounds.
Evaluate the safety profile of assigned marketed products for signal detection and trend analysis.
Initiate and lead clinical interpretation and evaluation of aggregate adverse event and product complaint data.
Support global safety team or surveillance initiatives to facilitate product safety issues discussion.
Collaborate with other teams and functions within Global Safety, as well as other Amylin functional groups and departments (i.e, Clinical, Regulatory, Quality, Medical Affairs) and corporate partners in PV and safety surveillance.
Identify important safety issues and analyze pharmacovigilance data and plan and prepare timely pharmacovigilance reports.
Author periodic safety and other reports (NDA, EU dossier) for submission.
Conduct safety analysis and collaborate with team members to identify relevant information for analysis work up (e.g. clinical data, epidemiology, outcome research, literature etc).
Support Senior Management of Pharmacovigilance on strategic planning and cross functional team programs and departmental initiatives.
Involved in the development and maintenance of SOPs, policies, procedures and standards for safety surveillance.
Support Regulatory Affairs projects as assigned
Healthcare degree from an accredited institution (i.e, PharmD, PA, NP, MSN, RN) or Bachelor degree in a scientific or other relevant discipline with pharmaceutical industry experience/training
International Pharmacovigilance experience highly desired and management experience preferred.
Minimum of 3 years experience working in a regulated environment (pharmaceutical or biotechnology).
Experience in pre-or post-approval safety activities, including safety processes and reporting.
Understand Good Clinical Practices, Food and Drug Administration (FDA) regulatory reporting requirements, and International Conference on Harmonization of Technical.
Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines.
Sound clinical knowledge and strong report writing and communication skills are essential.
Ability to read, analyze, and interpret scientific journals and regulatory documents.
Ability to write reports, medical summaries, and procedure manuals.
Excellent verbal and written communication skills, including presentation skills.
Proficient with all Microsoft Office software; and have working knowledge of safety database software (oAERS or ARGUS) and data query tool (COGNOS, Business Objects) are highly desirable, especially with clinical scientific data