Senior Pharmacovigilance Associate (Prague, Czech Republic)

Accenture Services, s.r.o.

Place of work
Bucharova 1314/8, 158 00 Praha-Stodůlky, Czech Republic, Prague
Contract type

Information about the position

Job description, responsibilities and duties

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 time frames 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

Employee perks, benefits

- 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.
- Home office

Requirements for the employee

Candidates with education suit the position

University education (Bachelor's degree)

Educational Specialization

Pharmacist, nurse or dentist

Language skills

English - Upper intermediate (B2)

Personality requirements and skills

- 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


Brief description of the company

Accenture’s Services workforce is a dedicated team of people who work on outsourcing engagements. These are long-term partnerships with clients for whom we manage and provide increasingly specialized business operations, such as finance and accounting, IT, applications development and maintenance, help desk services, and HR. We not only maintain key business functions for clients, we constantly seek to improve them to help our clients move ahead of the competition.

Number of employees

1000 an more employees

Company address

Accenture Services s.r.o.
V Parku 12
148 00 Praha
ID: 3254631   Datum zveřejnění: 29.12.2017