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Officer - Pharmacovigilance

0-2 years
3LPA - 5.5 LPA
10 Dec. 27, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Literature Screening and Case Processing Associate

Department: Research & Development

Industry Type: Clinical Research / Contract Research

Employment Type: Full Time, Permanent


Job Responsibilities:

Literature Screening:

  1. Review worldwide scientific and medical literature in compliance with company-controlled documents (e.g., SOPs, WIs, Guide) and relevant regulations.
  2. Maintain organized, documented records of all literature safety reports received and reported.
  3. Assist in the preparation, revision, and review of SOPs, WIs, templates, and training documents.
  4. Communicate urgent safety issues to the Line Manager.
  5. Ensure high professional standards in communication and maintain records of all internal and external communications.
  6. Support case processing tasks including data entry, drug coding, MedDRA coding, listedness, and narrative writing of ICSR.
  7. Basic entry of literature cases received from PubMed.
  8. Create safety IDs by uploading and importing received files or manually, as required.
  9. Perform duplicate searches and manage tracking of all cases from regulatory authorities.
  10. Weekly reconciliation of regulatory cases with their source of receipt.

Basic Entry:

  1. Basic entry of regulatory cases from regulatory authorities.
  2. Initiate and track received cases by creating safety IDs.
  3. Perform duplicate searches and manage the reconciliation of regulatory cases.
  4. Ensure adherence to local regulations and company-wide pharmacovigilance requirements.
  5. Deliver training to new joiners and team members as required.
  6. Support ICSR team leader and escalate issues or tasks outside normal scope.
  7. Assist group leader with timely submission of ICSR to maintain regulatory compliance.
  8. Case processing activities, including data entry, drug coding, MedDRA coding, listedness, causality assessment, and narrative writing in accordance with controlled documents and regulations.

MICC (Medical Information Case Communication):

  1. Ensure daily checks of medical enquiry e-mail, fax machine, phone, and postal systems for adverse events/medical inquiries/product inquiries.
  2. Track and handle medical inquiries according to SOPs and company guidelines.
  3. Log and update inquiries in the Medical Information database.
  4. Create safety IDs in the global safety database.
  5. Assist the medical reviewer in follow-up and communication of inquiries.
  6. Reconcile and acknowledge adverse events/product complaints as per safety data exchange agreements (SDEA and PMP).
  7. Participate in audit/inspection preparations and audits/inspections as appropriate.

Preferred Candidate Profile:

  • Qualifications: M.Pharm / Pharm D.
  • Experience: 0 to 2 years
  • Key Skills: Literature Screening, Pharmacovigilance

Role Category: Research & Development - Other