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Job specification: Join an interesting project supporting an international pharmaceutical company by providing data processing in the safety database for received source documents of cases collected during safety monitoring of drugs and compounds.
This includes triage, data entry, coding and narrative writing of individual case safety reports within agreed timeframes and to a high standard of accuracy, in compliance with Customer business rules, standard operating procedures and global regulatory requirements as documented in Customer’s SOPs
Additionally, the Senior Pharmacovigilance Associate ensures integrity and consistency of data against source document by performing QC and appropriate correction of all processed cases in appropriate timelines as per standard operation procedures.
Case intake, duplicate check, and registration of the case into the safety database
Case validation and triage
Data entry of Individual case safety reports into the safety database.
Full data entry including medical coding and safety narrative.
Responsible for medical coding (e.g. MedDRA, Company Product Dictionary, DRL code)
Review data entered in safety database for completeness and accuracy
Conduct Review and assessment of individual case safety reports obtained and route cases to approval via workflow
Perform causality assessment
Communicate and interact effectively
Follow up with sites regarding outstanding queries
Follow up on reconciliation of discrepancies
Handling case deletion if applicable
Perform other drug safety related activities as assigned
European trained and certified Health Care Professional (pharmacist, nurse or dentist)
Experience of ICSR management in a PV database (min 12 months), incl. triage, data processing and quality check
Experience in MedDRA coding execution ( LLT, PT, SOC, SMQs)
GVP modules - Especially module VI (Management and reporting of adverse reactions to medicinal products)
An overview of PV in post-marketing & clinical trials settings (assessment of Listedeness/expectedness against of IB/CCDS)
Experience in oncology is desirable
Fluency in oral and written English
High degree of accuracy and attention to detail in translation
Position in the world’s leading global company
Professional growth based on performance
Wide range of benefits – 5 weeks of holiday, meal vouchers, recreation/wellness vouchers, pension/life insurance etc.
By providing us your personal data in your CV, you have allowed Accenture to process and file your CV in the HR database. Your personal data will be used for the internal HR needs of Accenture only. At the same time you confirm herewith that the personal data as stated in the CV you have sent to us is true and accurate.
Benefits Notebook, contributions to the pension / life insurance, flexible start/end of working hours, meal tickets / catering allowance, holidays 5 weeks, educational courses, training, cafeteria, sick day