Instagram
youtube
Facebook

Pharmacovigilance Physician

1+ years
Not Disclosed
10 Nov. 8, 2024
Job Description
Job Type: Full Time Remote 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

About PrimeVigilance

PrimeVigilance, a part of Labcorp Drug Development, is a global leader in providing comprehensive pharmacovigilance and drug safety services. Our Pharmacovigilance Physician team operates in North America, Europe, and Asia, supporting the safety and efficacy of pharmaceutical products across their lifecycle.


Job Overview

The Pharmacovigilance Physician role at PrimeVigilance offers an exciting opportunity for Medical Doctors to begin or further develop a career in drug safety. As a member of the Pharmacovigilance team, you will be responsible for reviewing and approving post-marketing Individual Case Safety Reports (ICSRs), Serious Adverse Event (SAE) reports, and conducting medical/causality assessments. This role is essential to ensuring the safety of medicinal products and improving public health.


Key Accountabilities

  • ICSR & SAE Review:
    Review and approve post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports from clinical trials, ensuring accurate medical/causality assessments.

  • Coding & Assessment:
    Review includes the coding of adverse events, as well as assessments of seriousness, expectedness, and causality.

  • Medical Comments & Analysis:
    Provide Company comments, raise follow-up questions, and conduct analysis of similar events to ensure clarity and consistency in reporting.

  • Documentation:
    Complete all required supporting documentation, including safety trackers and other related reports.

  • Support the Qualified Person for Pharmacovigilance (QPPV):
    Collaborate with the QPPV (if not medically qualified) in the medical understanding and evaluation of any emerging safety issues.

  • Periodic Reports:
    Contribute to the review and drafting of periodic safety reports, ensuring timely and accurate submissions.

  • Literature Screening:
    Review literature screening strategies and analyze articles to identify any ICSRs, SAEs, or other safety-related findings relevant to the product.


Qualifications

  • Education:
    MD Qualification (Medical Doctor) is required.

  • Skills:

    • Strong ability to plan, organize, and prioritize tasks effectively.
    • Ability to work efficiently cross-culturally and cross-functionally, valuing teamwork and collaboration.
    • Excellent communication and presentation skills, with the ability to clearly convey complex medical information.
    • Advanced proficiency in English, both verbal and written (minimum B2 level).
    • Advanced knowledge of MS Office applications.

Why PrimeVigilance?

PrimeVigilance offers a dynamic and collaborative environment where Medical Doctors can grow and thrive in the field of pharmacovigilance. As part of a global team, you will have the opportunity to make a direct impact on drug safety and patient well-being.