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Senior Pharmacovigilance Assoc...

Senior Pharmacovigilance Associate (Prague, Czech Republic)

Accenture solves clients' toughest challenges by providing unmatched services in strategy, consulting, digital, technology and operations. We partner with more than three-quarters of the Fortune Global 500, driving innovation to improve the way the world works and lives. With expertise across more than 40 industries and all business functions, we deliver transformational outcomes for a demanding new digital world.

Accenture Operations combines technology that digitizes and automates business processes, unlocks actionable insights, and delivers everything-as-a-service with our team's deep industry, functional and technical expertise. So you can confidently chart your course to consuming your core business services on demand, accelerate innovation and speed to market. Welcome to the "as-a-service" business revolution.

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.

Responsibilities:
  • 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
Requirements:
  • 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
We offer:
  • Position in the world’s leading global company
  • Professional growth based on performance
  • Continuous training
  • Wide range of benefits – 5 weeks of holiday, meal vouchers, recreation/wellness vouchers, pension/life insurance etc.
How to apply:
If you are interested in working with us please send us your resume to email address veronika.langrova@accenture.com

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.

Job location
Bucharova 1314/8, 158 00  Praha-Stodůlky, Czech Republic

Employment type
Full-time work

Type of employment
Employment contract

Duration of employment
Permanent

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

Required education
Bachelor's

Required languages
English (advanced)