Pharmacovigilance Scientist

Continuum India

0-5 years

Not Disclosed

Chandigarh

10 May 2, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: As a Pharmacovigilance Scientist (Position Code: PVS001), your primary responsibility will be to manage activities related to adverse event (AE) and serious adverse event (SAE) processing, follow-up, analysis, and regulatory reporting for both marketed and investigational human and veterinary products, adhering to applicable regulatory requirements. Additionally, you will be responsible for the preparation of aggregate reports such as Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), Addendum to Clinical Overviews (ACOs), Addendum PSURs, PSUR Line Listings, and US Periodic Adverse Drug Experience Reports (PADERs) from aggregate data, following client conventions and requirements. You will also conduct quality checks of aggregate reports and perform signal detection-related analyses and reports, including cumulative analyses and issue event analyses.

Minimum Qualifications:

Master’s degree in Life Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, or Biophysics), or a degree in Dentistry, or Bachelor degree in Veterinary Sciences (B.V.Sc.), or Post-Graduation in Veterinary Sciences (M.V.Sc.).
Experience in the Pharmacovigilance industry is advantageous.
Good knowledge of medical terminology.
Fluency in written and spoken English.
Computer proficiency, including the ability to work with web-based applications.
Familiarity with the Windows 10/ Window 7 professional operating system and the MS Office suite (Word/Excel/Power Point).
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.

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