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Drug Safety Physician - Position Code: Dsp001

0-2 years
Not Disclosed
10 Jan. 3, 2025
Job Description
Job Type: Full Time Education: MBBS/MD 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

Here’s an updated and polished Pharmacovigilance job description based on the provided details:


Position: Pharmacovigilance Associate
Location: Chandigarh, India
Department: Pharmacovigilance
Company: [Company Name]


Job Overview

The Pharmacovigilance Associate will be responsible for preparing and reviewing safety reports, conducting signal detection activities, performing medical reviews of individual case safety reports (ICSRs) and clinical study reports (CSRs), and maintaining the risk management plans (RMPs) for assigned products. This position requires a solid understanding of pharmacovigilance principles and an ability to synthesize scientific data to ensure regulatory compliance.


Key Responsibilities

  • Report Preparation:
    Prepare periodic safety and risk reports, including Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), Addendum to Clinical Overviews (ACOs), Addendum PSURs, PSUR Line Listings, and US PADERs from aggregate data, in accordance with client conventions and regulatory requirements.

  • Quality Checks & Signal Detection:
    Conduct quality checks on aggregate reports, ensuring accuracy and completeness. Perform signal detection-related analyses including cumulative analyses, issue event analyses, and Signal Evaluation Reports or Drug Safety Reports.

  • Medical Review & Case Listings:
    Perform medical review of individual case safety reports (ICSRs), narratives for Clinical Study Reports (CSRs), and case listings. Provide medical advice to assist drug safety scientists in processing reports and narratives.

  • Client Interaction & Follow-Up:
    Interact with client personnel to discuss potential signals and issues detected with products. Follow up to obtain missing or incomplete information, resolving and clarifying any issues.

  • Risk Management Plans (RMPs):
    Support the preparation and maintenance of Risk Management Plans (RMPs) and ensure all documentation complies with client guidelines and global regulatory reporting obligations.

  • Regulatory Compliance:
    Ensure compliance with global regulatory reporting obligations and adhere to internal timelines for report submissions. Maintain records in compliance with internal guidelines and SOPs.

  • Medical Expertise & Safety Profiling:
    Maintain in-depth knowledge of the adverse event safety profile of assigned drugs, labelling documents, client guidelines, and Standard Operating Procedures (SOPs).

  • Published Literature Review:
    Perform regular review of published literature to support safety surveillance activities.


Qualifications & Requirements

  • Education:

    • A degree in Medicine (MBBS) or a post-graduate qualification (MD), preferably in a clinical branch.
    • Ayurvedic, homeopathic, veterinary doctors or professionals from other alternative medical streams and life sciences scientists are not eligible for this position.
  • Skills & Competencies:

    • Strong ability to synthesize scientific data and provide concise, accurate, and unambiguous medical synopses.
    • Proficiency in medical text writing and interpretation of clinical data.
    • Excellent fluency in written and spoken English.
    • Solid proficiency in Windows 10/Windows 7 operating systems and MS Office Suite (Word, Excel, PowerPoint), with the ability to work with web-based applications.
    • Attention to detail and ability to accurately transcribe and type data.
    • Strong organizational skills to ensure compliance with regulatory timelines.

Why Join Us?

At [Company Name], we provide a stimulating environment where you can contribute to enhancing patient safety globally. As part of our team, you'll have the opportunity to grow your career in the dynamic field of pharmacovigilance. We offer competitive compensation and a collaborative workplace culture.

To apply, visit [Company Careers Page or Job Application Link].


This job description incorporates all essential functions, qualifications, and skills for the Pharmacovigilance Associate position while maintaining a clear and concise structure. Let me know if you would like to modify or add further details!

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