Pharmacovigilance Specialist
Ponúka:
K dispozícii pre podujatie:
Opis pracovnej ponuky
- 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
Požiadavky na pracovné miesto
- 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