Associate Medical Director, Product Safety

2 mesi fa

Milano, Italia Pfizer A tempo pieno

Pfizer is hiring a Talented and Enthusiastic Associate Medical Director to join the Gastro, Women Health, Biosimilar Therapeutic Area within Corporate Safety based in Milan, Italy.
- Why Patients Need You
- Associate Medical Directors within Global Safety assess and process adverse event reports received worldwide thus actively contributing to updated and complete product safety profiles.
- Key Experience Offer of this Role
- 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.
- What You Offer
- Medical Degree from an accredited institution
- One to two years of experience as an MD in clinical practice
- One to two years of relevant experience in pharmacovigilance, clinical research or related field
- Pharmaceutical industry experience preferred
- Working knowledge of international regulations and guidance documents as related to worldwide reporting requirements, preparation of clinical trial safety assessments, and regulatory submissions including the preparation of aggregate reports
- Fluency in oral and written English; knowledge of additional language(s) an advantage
- 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
- Ability to achieve personal objectives while meeting departmental standards of performance
- Experience and skill with medical writing an advantage
- Adherence to Pfizer Values: Courage, Excellence, Equity and Joy
Purpose
-Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
-Digital Transformation Strategy
-One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
-Flexibility
-We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation
-Equal Employment Opportunity
-We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

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