Navitas Job opening for Junior Micc Associate - Pharmacovigilance and Safety Apply here

Navitas Job opening for Junior Micc Associate – Pharmacovigilance and Safety Apply here

We are currently seeking a Junior MICC Associate to join our growing team.

Working within the Medical Information Contact Centre (MICC) for the Pharmacovigilance function you will:

Follow both global and local regulations to protect personal and client related data as per company policy.
Be responsible for receiving calls/Email (AE, PQC, MI & GI), case intake, duplicate check, and registration
Follow up Inquiry through phone, email including translation of inquiry if not in a primary language (English)
Be required to always exhibit a detail-oriented etiquette and friendly attitude when answering telephone calls.
Ensure that calls are appropriately escalated to supervisor when necessary
Ensure timely completion of internal/external training as and when assigned
Participate/Support in Audits and responsible for closing CAPAs on time
Provide support in other MICC related activities as per the business requirement.

Within the role you will be responsible for the following:

Data entry of individual case safety reports (all case repost types) into the safety database
Review and evaluate AE case information to determine required action based on, and following, internal policies and procedures
Process all cases to meet timelines as per prioritization with defined quality and productivity to meet project SLAs and KPIs
Coding all medical history, events, drugs/procedures/indications, and laboratory tests according to the appropriate dictionary (For e.g. MedDRA, Company Product Dictionary, WHO-DD)
Writing and/or checking for correctness and completeness of the medically relevant safety narrative in chronological order
Checking the completeness and accuracy of the data entered in the various fields
Source document preparation and archival, as required
Perform necessary changes in the demoted/back routed cases from Quality reviewer/Medical reviewer
Review the QR feedback received and, if necessary, ensure that the feedback comments are addressed
Co-ordinate with other workflows as required
Act as a Subject Matter Expert for assigned projects, providing review feedback, mentoring, and training team to enhance quality