Instagram
youtube
Facebook

Pharmacovigilance Scientist - Position Code: Pvs001

3+ years
Not Disclosed
10 Jan. 3, 2025
Job Description
Job Type: Full Time Education: MBBS/MD/BVSc/MVsc/MSc 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 a refined version of the Pharmacovigilance job description for the position located in Chandigarh:


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


Job Overview

The Pharmacovigilance Associate will be responsible for managing activities related to the processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for both marketed and investigational human and veterinary products. The role ensures compliance with regulatory requirements and supports the preparation of aggregate safety reports, including Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), and similar documents.


Key Responsibilities

  • Adverse Event Management:
    Process, analyze, and report AEs and SAEs for marketed and investigational products in accordance with applicable regulatory requirements.

  • Aggregate Report Preparation:
    Prepare aggregate reports, such as PBRERs, PSURs, Addendum PSURs, PSUR Line Listings, and US PADERs, based on data collected for products. Ensure these reports are in line with client conventions and regulatory guidelines.

  • Quality Checks:
    Perform quality checks on aggregate reports, ensuring the accuracy and completeness of the data before submission.

  • Signal Detection & Analysis:
    Conduct signal detection activities and perform analyses related to cumulative data and issue event identification. Prepare reports based on findings.

  • Regulatory Compliance:
    Ensure all pharmacovigilance activities comply with the applicable national and international regulatory requirements.

  • Data Evaluation:
    Analyze data and draw conclusions independently, providing concise and accurate summaries of medical text and data.


Qualifications & Requirements

  • Education:

    • Master’s degree in Life Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology, or Biophysics).
    • Bachelor's degree in Veterinary Sciences (B.V.Sc.) or Post-Graduation in Veterinary Sciences (M.V.Sc.).
    • Experience in the Pharmacovigilance industry would be an advantage.
  • Skills & Competencies:

    • Proficiency in medical terminology and fluency in both written and spoken English.
    • Ability to write unambiguous medical text and make relevant synopses of medical data.
    • Strong written and oral communication skills are required.
    • Ability to evaluate data and draw conclusions independently.
    • Proficient with MS Office Suite (Word, Excel, PowerPoint) and familiarity with Windows 10/Windows 7 professional operating systems.
    • Competence in using web-based applications and managing pharmacovigilance databases.

Preferred Qualifications:

  • A background or experience in Pharmacovigilance is preferred, especially in areas of aggregate report preparation, signal detection, and regulatory reporting.

Why Join Us?

At [Company Name], we offer a dynamic working environment where you can grow your career in the growing field of pharmacovigilance. Join our team and make an impact in improving patient safety globally.

For more information and to apply, visit: [Company Careers Page or Job Application Link]


This description provides a comprehensive overview of the role while highlighting the essential qualifications and responsibilities. Let me know if you'd like further adjustments!