Clinical trial and drug safety expert (m/f/n) – Freelance – on hold

  • Position zu besetzen ab 2. August 2021
  • Permanent-ID OCR-FL-1383
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland
  • Kategorien Beschäftigungsform, Branche, Freelance/Contracting, Pharma

Signal detection activities

  • Reviewing reports and data in dedicated tools (e.g. Spotfire, EVDAS, Empirica Signals, as applicable) for signal detection purposes
  • Reviewing and assessing clinical and safety database outputs; medically/scientifically analyzing and interpreting aggregate safety data from clinical trials and post-marketing sources
  • Reviewing the scientific literature (non-ICSR literature) for safety surveillance and signal detection purposes
  • Analyzing safety signals (including authoring the signal evaluation report, and BRAT, PVAB, MSEB and LDB meeting contributions)
  • Developing and maintaining MedDRA CMQs for the analysis of potential signals and aggregate safety data
  • Contributing to the development of Emerging Safety Issue Reports and respective communication to external stakeholders

 

d(RMP) and periodic report

  • Delivering content related input into (d)RMPs (document author)
  • Delivering content related input into periodic safety reports (document author)
  • Providing responses to HA questions related to RMPs or periodic safety reports

 

Clinical trial activities

  • Providing safety related input into the development of other clinical trial related documents such as IMPD, IB and ICF clinical trial protocols, integrated analysis plan, clinical trial reports, clinical trial database set up
  • Be able to support a program with ongoing PhI to Ph III studies safety
  • Providing safety related input for data monitoring committees (i.e. charters, meeting minutes, slide preparation, data review)
  • Providing responses to HA questions related to clinical trials (applications)

 

Other

  • Review of ph I/II data to establish safety profile and monitoring
  • Developing product-specific trainings for internal or external stakeholders
  • Providing expert input into the standardization and improvement of processes within GPS
  • Be able to deputize the Safety Strategy lead as required
  • Be able to present as safety committees or boards

 

in-licensing

  • Provide support to in-licensing activities (Database transfer)

 

Languages

  • English – Must Have
  • Other Languages good to have but not required

 

Additional information:

Location: Remote

Project start: 02.08.2021

Availability: 4-5 days / week

Project duration: 12 months

Remote support: 100%

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