Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
December 26, 2022
Supports the planning and preparation of aggregate safety reports such as the Development Safety Update Report, Periodic Benefit Risk Evaluation Report, periodic line listings, ad-hoc analyses, etc.
December 30, 2022
Maintains and establishes the global/regional pharmacovigilance (PV) system in collaboration with partner organizations, local marketing authorization holders (MAHs) and Vendors.
March 20, 2023
Assists with the development of safety sections of study protocols, clinical study reports, investigator brochures, and other related clinical documents.
March 21, 2023
Management and review of trends and report significant investigation/deviation issues and system deficiencies to senior management, as appropriate.
March 24, 2023
Works closely with PV Clinical Managers to be aware of any safety issues / concerns and assist or leads special projects as assigned by and under the direction of the US Drug Safety PV Clinical Manager and/or other Safety personnel.
March 24, 2023
Provides sponsor oversight of SAE processing by outsourced vendors, including the review and monitoring of compliance through various monitoring reports and other oversight activities.
April 11, 2023
Participate in the development or revision of PV Partner Management-related standard operating procedures and working instructions.
May 05, 2023
Participates in the quality management system in Drug Safety including ensuring department standards are met, including training requirements, monitoring performance, implementing continuous improvement actions and good documentation practices.
May 09, 2023
