Senior Pharmacovigilance Associate

Náplň práce, pravomoci a zodpovědnosti

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.

WHAT ARE YOUR 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

ARE YOU OUR IDEAL CANDIDATE?

* 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)
* Fluency in oral and written English
* High degree of accuracy and attention to detail in translation

Minimální požadované vzdělání: Secondary with school-leaving examination

Znalosti

• Language skills
  • English - Upper intermediate (B2)

Práce v oboru: Administrativa

Lokality: