Drug Safety Expert (m/f/x) - in Munich (PR

Our costumer, an international pharmacompany, is seeking highly qualified candidates to fill the position

Drug Safety Scientist (m/f/x)

in Munich

 

Key resp

onsibilities:

• Supports preparation of submission documents for marketing authorization applications (MAA) for oncology products requested by European authorities
• Supports the generation of Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), Risk Management Plans (RMPs) and Signal Detection Reports
• Supports oncology group in assessing the medical risk of oncology product complaints and to initiate the necessary actions if needed
• Supports in creating, proposing and implementing risk mitigation actions for a new oncology product
• Performs triage of incoming cases of Individual Case Safety Reports (ICSRs) and clinical trial serious adverse events
• Review of study synopses/protocols, investigators brochures, study reports and regulatory documents
• Contribution and support of Regulatory Affairs department concerning creation of regulatory documents

 

Professional experience and personal skills:

• Graduate degree in Health Sciences (PharmD, PhD), molecular biology, biochemistry, pharmacy or equivalent educational background combined with professional experience in pharmacovigilance and clinical safety
• 2-3 years working experience in Drug Safety including experience in post marketing surveillance / drug safety operations
• Detailed knowledge of the use of drug safety databases, individual case processing experience and practical expertise with MedDRA
• Thorough understanding of ICH-GCP, cGMP, EMA Guidelines and European Regulations and Directives, and other national regulatory requirements pertaining to adverse event assessment and reporting
• Able to interpret safety data and to write safety texts for MAA dossiers
• Personal integrity and high degree of confidentiality
• Ability to handle and prioritize multiple complex projects and tasks simultaneously and to work independently
• Fluent in English and German, both in oral and written communication

 

The offer:

Our customer offers an interesting, diversified and challenging position, good contractual conditions, flexible working models, all the social benefits of a modern company and a professional environment where you will have the opportunity for personal growth.

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