Drug Safety Reporting Specialist II
Our team of colleagues in clinical research services are at the forefront of getting cures to market. We bring a high caliber of scientific and clinical expertise to the development of drugs that address the world’s most challenging health concerns. Our Clinical Research team, who powers our PPD® clinical research portfolio, are part of our leading global contract research organization (CRO).
Job Description
Receives, prepares, and submits safety reports to applicable parties. Escalates to lead and/or line manager if any issues are encountered. Ensures reports are submitted in compliance with regulatory timelines and country legislation.
Assists in producing metrics and alerts manager to any quality or timeline issues.
Participates on project teams and may lead projects of small to moderate scope. Provides training and support to other team members.
Performs administrative tasks such as filing and the maintenance of safety reporting systems and information.
Liaises with various departments around safety reporting tasks and the setting up of client accounts.
Participates in audits where required and performs testing activities as needed.
Shares ideas and suggestions with team members ensuring effective communication and participates in process improvement initiatives.
Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
All U.S. colleagues are required to disclose their COVID-19 vaccination status. New hires will be asked to disclose their vaccination status upon the first day of employment.
U.S. new hires (including those in Field Sales, Field Services and Customer Support – Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing.
U.S. and Canada new hires in Clinical Research who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), Assistant CRA (ACRAs), all CRA and ACRA line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles.
Canada new hires (including those in Field Sales, Field Services, and Customer Support Technical Applications) may be required to be vaccinated against COVID-19, including boosters, based on the customer or client sites they visit and support. Individuals may also be required to comply with other COVID-19 health and safety protocols, such as masking or testing. New hires in Field Sales, Field Services, and Customer Support Technical Applications will be asked to disclose their vaccination status upon the first day of employment.
