Expert* Pharmacovigilance – Signal Detection – freelance – on hold

  • Standort Deutschland / 6x
  • Kategorien Branche, Freelance/Contracting, Pharma

Tasks:
• Detect signals using safety data sets from various sources, such as spontaneous adverse event lists, clinical trial data sets, reports or observational study data sets, and present meaningful summaries of the data
• Analysing safety signals
• Write reports on the assessment of signals and present the results to governing bodies as required
• Examine publications from the scientific/medical literature for important safety information
• Summarise and critically evaluate findings from these publications for safety reports (e.g. PSURs, signal assessment reports)
Regular safety reports:
• Contribute individual key safety sections for the production of aggregated safety reports (Periodic Safety Update Reports, Development Safety Update Reports, etc.) according to planned schedules and in collaboration with other functions

Benefit Risk Management:
• Contribute to risk management activities, including the production of safety-related justification documents in support of key corporate/development safety information and safety-related labelling updates
• Risk communication
• Risk management plans

Submissions:
• Support in responding to health authority enquiries
• Contribution to safety-related content for HA
• Briefing books
• Integrated summary of safety analyses CTD modules
• Extensions and safety variations

Clinical trials:
• Conduct aggregate safety monitoring analyses during study conduct
• Individual safety-related input for the preparation of submission dossiers
• Investigator brochure and informed consent form as well as other study-related documents

Skills:

Education:
• At least Master’s degree (or equivalent international degree) in natural sciences, medicine/health sciences or pharmaceutical sciences
Experience:

• At least 5 years of progressive experience in the pharmaceutical/biotech industry or with a health authority and advanced experience in pharmacovigilance
• Experience in signal management – particularly signal detection in multiple data sources across the product lifecycle, and problem solving in the methods and approaches used to respond to complex regulatory enquiries
Competencies:

• Advanced understanding of pharmacovigilance and global clinical safety methodology and regulations
• guidelines and standards
• Understanding of ICH GCP and drug development
• Computer skills in database entry and graphing (e.g. Spotfire)
• Excellent written and oral communication skills in English with the ability to evaluate, interpret and summarise scientific data
• Self-motivation, ability to set priorities and plan effectively
• Ability to work independently and as part of a team
• Work in a cross-functional environment

Additional Information:
Location: Darmstadt / remote
Project start: 01.02.2022
Project duration: 12 months
Project scope: 40 hours / week
Remote share: 90 %