Senior Executive / Specialist, Pharmacovigilance Consultant

at  ClinChoice

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice, is searching for a Senior Executive/Specialist, Pharmacovigilance Consultant to join one of our clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

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).

• 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.