Medical Director – Product Safety Surveillance and Reporting

Azienda:
Human Value
Dettagli annuncio
DATA DI PUBBLICAZIONE
17/12/2021
LUOGO
Lombardia/Milano

SETTORE
Chimico, farmaceutico

CATEGORIA - RUOLO
Direzione Generale e Management; Sanità & Servizi Sociali

ANNI DI ESPERIENZA
oltre 10 anni

CONTRATTO
Tempo indeterminato

Our Client

Our Client is Pfizer, a leader for over 150 years in the development, manufacturing and marketing of safe and effective drugs for the treatment and prevention of diseases, both common and rare.
We are supporting the Company in the identification of a Medical Director who will join the Global Safety Team based in Milan and will be dedicated to the cardiovascular, endocrine and metabolic therapeutic area.
 
 

The Role

The Global Safety team aims to evaluate and process adverse event reports from around the world, thus actively contributing to updating and completing product safety profiles. 
As part of a team with continuous world-wide interactions, the Medical Director will have the following 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.

The Requirements

  • 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.
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