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Pharmacovigilance Scientist

2+ years
Not Disclosed
11 Nov. 26, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences/Biotechnology, or Biophysics) or a degree in Dentistry or Veterinary Sciences (B.V.Sc. / M.V.Sc 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
Position Code: PVS001
Location: Chandigarh
Job Type: Full-Time


Job Overview:

The Pharmacovigilance Scientist will manage 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. This role will ensure compliance with applicable regulatory requirements and contribute to the preparation of aggregate reports such as PBRERsPSURs, and PADERs.


Key Responsibilities:

  • Process and analyze adverse event reports and perform regulatory reporting in line with industry standards.
  • Prepare and quality-check aggregate reports including PBRERsPSURs, and PADERs.
  • Conduct signal detection-related analyses, including cumulative and issue event analyses.
  • Synthesize data and write clear, unambiguous medical summaries.
  • Collaborate with cross-functional teams to ensure data accuracy and regulatory compliance.

Qualifications:

  • Educational Requirements:
    • Master’s degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, or Biophysics) or a degree in Dentistry or Veterinary Sciences (B.V.Sc. / M.V.Sc.).
    • Experience in the Pharmacovigilance industry is preferred.
  • Skills & Attributes:
    • Good knowledge of medical terminology.
    • Fluency in written and spoken English.
    • Computer proficiency with MS Office (Word, Excel, PowerPoint).
    • Ability to analyze data independently and write concise, accurate reports.
    • Strong written and oral communication skills.

About the Role:

This position provides an excellent opportunity to engage in critical pharmacovigilance activities that contribute to drug safety and regulatory compliance. The successful candidate will play a key role in ensuring product safety and will be involved in the preparation of safety reports and signal detection.


This is a key role for professionals looking to advance in the pharmacovigilance field, focusing on safety monitoring and regulatory compliance in both human and veterinary pharmaceuticals.