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Junior Micc Associate

Navitas Life Sciences
Navitas Life Sciences
1-3 years
Not Disclosed
12 May 20, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Junior MICC Associate

We are currently seeking a Junior MICC Associate to join our growing team. This role involves working within the Medical Information Contact Centre (MICC) for the Pharmacovigilance function.

Responsibilities:

General Duties:

  • Adhere to global and local regulations to protect personal and client data as per company policy.
  • Handle calls/emails related to Adverse Events (AE), Product Quality Complaints (PQC), Medical Information (MI), and General Inquiries (GI).
  • Conduct case intake, duplicate checks, and registration.
  • Follow up on inquiries via phone and email, including translation if not in English.
  • Exhibit detail-oriented etiquette and a friendly attitude when answering calls.
  • Escalate calls to the supervisor when necessary.
  • Complete internal/external training promptly.
  • Participate in and support audits, ensuring timely closure of Corrective and Preventive Actions (CAPAs).
  • Provide support for other MICC-related activities as required.

Individual Case Safety Report (ICSR):

  • Enter individual case safety reports into the safety database.
  • Review and evaluate AE case information to determine required actions based on internal policies and procedures.
  • Process cases to meet timelines, quality, and productivity standards to fulfill project Service Level Agreements (SLAs) and Key Performance Indicators (KPIs).
  • Code medical history, events, drugs/procedures/indications, and laboratory tests according to appropriate dictionaries (e.g., MedDRA, Company Product Dictionary, WHO-DD).
  • Write and/or verify the correctness and completeness of medically relevant safety narratives in chronological order.
  • Check data entered in various fields for completeness and accuracy.
  • Prepare and archive source documents as required.
  • Make necessary changes in cases demoted/back-routed by Quality Reviewer/Medical Reviewer.
  • Address feedback comments from Quality Reviewer (QR).
  • Coordinate with other workflows as required.
  • Act as a Subject Matter Expert for assigned projects, providing review feedback, mentoring, and training to enhance quality.

Desirable Skills and Experience:

  • 1-3 years of experience in an MICC role.
  • Graduate or postgraduate degree in life sciences.
  • Strong communication skills for effective client communication and coordination.