Specialist - Case Processing

Primary 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.
• Experience in raising follow-up queries, as necessary, with appropriate documentation in the
  safety database.
• Experience in ARGUS database.
• Experience in rare disease portfolio.
• 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.

Qualification

• Masters in science or above and in alignment with project / business team requirements.