• Active participation in the preparation and finalization of Safety Update Reports (SUR) for submission:
  • Stock keeping unit (SKU) mapping reviews linked to sales data
  • Manual calculation of doses sold and percentage incidences of adverse event reports
  • Data integrity - pulling case line listings and performing data quality checks on cases in the PV database within the scope of SUR preparation
  • Extraction and adaptation of SUR templates according to working instructions
  • Reviewing regulatory information to ascertain PV related safety actions or requesting regulatory information from product responsible Regulatory Affairs (RA) managers
  • Uploading and finalization of reports on shared portal
  • Liaising and working closely with colleagues in RA and local PV teams to ensure the timely transmission SURs to competent authorities
  • Support with the preparation of PV documents (e.g., Requests for PV Information (RPI), PV statements, Product Benefit Risk Evaluation Reports) and archiving all PV related communications
  • Miscellaneous – pro-active collaboration with other PV Specialist colleagues on various tasks 

Job requirements

  • Associate degree in life sciences (bachelor’s degree - desired)
  • Experience working in a GMP/compliance environment subject to authority inspections and knowledge of legal PV requirements and PV report preparation
  • Fluent in spoken and written English, fluency in German is an asset
  • Good Understanding of MS Office tools and Electronic document management systems

 

Angaben zur Stelle
Bildungsbereich:
Work experience:
Work experience is not required
Sprachkenntnisse:
  • English
  • Fluent
Anzahl von Stellen:
1
Date of expiry:
About company

As a leading personnel service agency in the areas of IT, engineering and life sciences, GULP brings companies and highly qualified experts together: Freelancers in projects, employees via temporary assignments to interesting companies or employees in permanent employment. In order to meet the changing requirements of customers and candidates, GULP offers a wide range of possibilities for cooperation: Customers of different industries and company sizes receive a solution that allows them to plan flexibly without having to forego the required expertise. Candidates choose the job offer that suits their current needs - when starting out in professional life, on the way to a new… Erfahren Sie mehr

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