Instagram
youtube
Facebook

Drug Safety Physician - Position Code

3-5 years
Not Disclosed
11 Nov. 26, 2024
Job Description
Job Type: Full Time Education: MBBS or a post-graduate qualification (MD) in a clinical branch. 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: Pharmacovigilance Scientist
Location: Chandigarh
Job Type: Full-Time


Job Overview:

The Pharmacovigilance Scientist will manage key pharmacovigilance activities, ensuring accurate adverse event (AE) reporting and regulatory compliance for both marketed and investigational products. The role involves preparing and quality-checking aggregate safety reports, signal detection analyses, and providing medical reviews for individual case safety reports (ICSRs) and clinical study reports (CSRs). The successful candidate will work closely with internal teams and clients to address product safety concerns and ensure adherence to regulatory timelines.


Key Responsibilities:

  • Report Preparation:

    • Prepare PBRERsPSURsPADERsACOsPSUR Line Listings, and other safety reports from aggregate data.
    • Conduct signal detection analyses, including cumulative and issue event analyses, and prepare related reports like Signal Evaluation Reports and Drug Safety Reports.
  • Medical Review & Support:

    • Perform medical review of ICSR narratives and Clinical Study Reports (CSRs).
    • Provide medical advice to drug safety scientists to assist in processing safety reports and narratives.
  • Regulatory Compliance:

    • Ensure compliance with global regulatory reporting obligations and organize workload to meet internal and regulatory timelines.
    • Support preparation and maintenance of Risk Management Plans (RMPs).
  • Client Interaction & Documentation:

    • Interact with client personnel to discuss potential signals and issues detected with products.
    • Follow up with clients to resolve incomplete or missing information.
  • Safety Profile & Vigilance:

    • Maintain in-depth knowledge of assigned drugs’ adverse event safety profiles, labeling documents, and client SOPs.
    • Monitor and review designated medical events, including published literature and case listings.

Qualifications:

  • Educational Requirements:
    • MBBS or a post-graduate qualification (MD) in a clinical branch.
  • Skills & Attributes:
    • Ability to synthesize and interpret scientific data and provide concise, accurate summaries.
    • Strong fluency in written and spoken English.
    • Proficiency with Windows 10/7 and MS Office (Word, Excel, PowerPoint).
    • Attention to detail and high accuracy in typing and transcription.

Note:
Candidates with a background in Ayurveda, HomeopathyVeterinary Sciences, or alternative medical streams will not be considered for this role.


This position is ideal for individuals with a strong medical background (MBBS/MD) and experience or interest in pharmacovigilance, regulatory reporting, and safety analysis, contributing significantly to patient safety and regulatory compliance.