Navitas Life Sciences Job Opening for JUNIOR MICC ASSOCIATE- apply Now

Navitas Life Sciences Hiring for Regulatory Associate

Navitas Life Sciences Job Opening for JUNIOR MICC ASSOCIATE- apply Now

Navitas Life Sciences Job Opening for JUNIOR MICC ASSOCIATE- apply Now

Bangalore, India

Graduate/Post Graduate with a life sciences degree

 Associate

 Pharmacovigilance and Safety

 Full Time

Job Description

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:

Individual Case Safety Report

  •  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

Desirable Skills and Experience

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

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