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Pfizer is hiring a talented and enthusiastic Medical Director to join the Cardiovascular, Endocrine and Metabolic Therapeutic Area within Corporate Safety based in Milan, Italy.
Why Patients Need you
Medical Directors within Global Safety assess and process adverse event reports received worldwide thus actively contributing to updated and complete product safety profiles.
Experience offered by the role
- Candidate will be emerged in a multinational setting with team colleagues in the United States and Asia stimulating diverse professional interactions
- Candidate will be considered a highly valuable resource and will be professionally mentored to acquire necessary skills to optimally perform his/her job
- Candidate will have the opportunity to take on challenges outside his/her comfort zone
Primary responsibilities
- Perform single case medical assessment, including the determination of seriousness, expectedness/listedness/labeledness, and causality of adverse events in compliance with current regulations, internal and external guidance documents, Standard Operating Procedures, Safety Job Aids, the Argus User Reference Guide and case processing/coding conventions.
- Maintain the timely submission of expedited reports.
- Support the achievement of the Therapeutic Area’s case processing performance timelines.
- Identify cases that meet SUSAR reporting criteria, prepare the SUSAR narrative, perform risk assessment, initiate the unblinding process (as appropriate), and make the report available for distribution.
- Take responsibility for inspection readiness for medical assessment activities; support regulatory authority inspections when needed.
- Develop and maintain comprehensive and current knowledge (e.g., indications, labeling documents, pharmacology) for the assigned product portfolio, current regulations governing the processing and reporting of safety data, Standard Operating Procedures, Safety Job Aids, and case processing/coding conventions, consistently completing curriculum training by the specified due dates.
Qualifications
- Medical Degree from an accredited institution
- Minimum of two years of relevant experience in pharmacovigilance, clinical research or related field
- Working knowledge of international regulations and guidance documents as related to worldwide reporting requirements
- Fluency in oral and written English
- Demonstrated computer literacy, with proficiency in the use and management of safety databases, including the Pfizer Global Safety Database, Argus Safety, and MS Window, Excel, Word and Outlook
- Adherence to Pfizer Values: Courage, Excellence, Equity and Joy.
Type of contract: permanent
Worklocation: Milan
Please send your application to ilaria.losinno@pfizer.com. CV is required in English.
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