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International Drug Safety Professional
1 tydzień temu
Role Overview
Pfizer's Worldwide Safety department is seeking a skilled Drug Safety Surveillance / Pharmacovigilance Associate to join its team in Milan, Italy.
The successful candidate will be responsible for reviewing, preparing, and completing individual case safety reports of adverse drug experiences originating from any source (either investigational or post-marketing) in the global safety database, to determine the safety profile of Pfizer's products and meet regulatory requirements, empowering healthcare decisions regarding the safe and appropriate use of medicines for patients.
This role requires strong knowledge of pharmacovigilance processes and procedures, as well as excellent communication and problem-solving skills. The ideal candidate will have a solid understanding of regulatory compliance and be able to work effectively in a team environment.
Responsibilities
- Apply corporate and global regulations, guidelines, Standard Operating Procedures, and writing practices, data entry conventions, and search functions in the safety database.
- Develop and maintain expertise and knowledge of all products within the Pfizer portfolio.
- Liaise with key partners, including Pfizer Country Organizations, Clinical Development, and other stakeholders regarding safety data collection.
- Collaborate with quality lines and relevant project team subject matter experts to ensure the accuracy and quality of information presented in assigned cases.
Qualifications
- Bachelor's degree in a science-related field, Pharmacy, or equivalent.
- Experience in pharmacovigilance, regulatory, or in clinical or scientific research is an advantage but not a requirement.
- Fluent English comprehension, reading, and speaking skills (B2 or higher), and German or French (B2 or higher) is a requirement.
- Ability to manage data in a Safety database (Argus preferred) is an advantage but not a requirement.
- Microsoft Office competent user (mainly Word, PowerPoint, Excel).
