Senior Executive/Specialist, Pharmacovigilance Consultant
Senior Executive/Specialist, Pharmacovigilance Consultant
ClinChoice
Poland
Main Job Tasks and Responsibilities:
- Experience in Intake/Triage, Data Entry, Quality Review, Case Finalization/Distribution of cases received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials;
- Mailbox monitoring;
- Experience raising and reviewing follow-up queries, as necessary, with appropriate documentation in the safety database;
- Experience ARGUS database;
- Experience in Literature review would be a value add.
Education, Experience and Skills:
- Bachelor’s degree in science or above;
- Experience in Rare disease and Oncology;
- Possess good communication skills;
- Experience training/mentoring new joiners;
- Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements;
- Training and mentoring skill (ICSR, Safety database etc.);
- Must have hands on experience with MS office applications (Outlook, Excel, Word, Power Point etc.).
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