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Pharmacovigilance Scientist - Position Code: Pvs001

0-2 years
Not Disclosed
10 Feb. 17, 2025
Job Description
Job Type: Full Time Education: B.V.Sc./M.V.Sc/BDS/M.Sc/M.Pharm 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

Pharmacovigilance Scientist - Position Code: PVS001:
Location: Chandigarh:

Job Responsibilities:

  • Manage activities related to the processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for marketed and investigational human and veterinary products in accordance with applicable regulatory requirements.
  • Aggregate report preparation (e.g., Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), Addendum to Clinical Overviews (ACOs), Addendum PSURs, PSUR Line Listings, US Periodic Adverse Drug Experience Reports (PADERs)) from aggregate data for products, in accordance with client conventions and requirements.
  • Perform quality checks of aggregate reports.
  • Conduct signal detection-related analyses and reports including cumulative analyses, issue event analyses.

Minimum Qualification(s):

  • Master’s degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, or Biophysics) or a degree in Dentistry or 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.
  • Good knowledge of medical terminology.
  • Fluency in written and spoken English.
  • Computer proficiency and ability to work with web-based applications.
  • Familiarity with the Windows 10/Window 7 professional operating system and the MS Office suite (Word/Excel/PowerPoint).
  • Capability to make concise, accurate, and relevant synopses of medical text and data.
  • Ability to write unambiguous medical text.
  • Ability to evaluate data and draw conclusions independently.
  • Strong written and oral communication skills are required.