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Senior Pharmacovigilance Specialist

5+ years
Not Disclosed
10 Jan. 31, 2025
Job Description
Job Type: Full Time Education: PharmD/MD/PhD 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

📌 Senior Pharmacovigilance Specialist | Clarivate – Karnataka, India

💼 Company: Clarivate
📍 Location: Karnataka, India (Hybrid Work Mode)
🕒 Job Type: Full-Time
🌍 Category: Life Sciences & Healthcare

Role Overview

As a Senior Pharmacovigilance Specialist at Clarivate, you will be responsible for conducting complex biomedical literature searches and analyses using databases such as MEDLINE, Embase, and Biosis Previews. This role involves mentoring team members, designing search strategies, and ensuring comprehensive literature screening for adverse event reporting, safety signal detection, and regulatory submissions.

Key Responsibilities

  • Develop and refine literature search strategies for scientific databases (e.g., MEDLINE/PubMed, Embase, Biosis Previews).
  • Conduct literature searches for NDA, PSUR, DSUR, AER, and other safety-related information, focusing on adverse events, safety signals, and emerging risks.
  • Mentor and train new recruits, organize refresher training sessions, and ensure training records are up to date for audits.
  • Work with clients to ensure accurate and efficient search strategies for safety information retrieval.
  • Maintain awareness of new drugs, therapeutic areas, and biomedical terminology in the literature.
  • Cooperate with specialists to address system-related issues and enhance retrieval strategies.
  • Engage with customers during pre- and post-sales processes, ensuring tailored solutions.

Candidate Requirements

🎓 Education & Experience:

  • Bachelor’s/Master’s degree in Pharmacy, Life Sciences, Nursing, Chemistry, Information Sciences, or a related field.
  • Advanced degree (e.g., PharmD, MD, PhD) preferred.
  • At least 5 years of experience in biomedical literature review for adverse event reporting and literature screening.
  • In-depth knowledge of pharmacovigilance principles, adverse event reporting, signal detection methodologies, and regulatory guidelines (e.g., ICH, GVP).

💼 Skills:

  • Proficient in biomedical terminology and therapeutic areas.
  • Strong understanding of pharmacovigilance regulations and adverse event reporting requirements.
  • Excellent writing skills for summarizing complex data and creating precise documentation.
  • Experience with literature searching platforms like Dialog, PubMed, and the application of thesauri like MeSH and Emtree.
  • Ability to collaborate effectively with internal teams and clients to tailor search solutions.

Why Clarivate?

Clarivate offers a supportive working environment with opportunities for professional growth and personalized training. The team works across multiple global customers and therapeutic areas, providing a dynamic and collaborative space for learning and development.

How to Apply

Interested candidates can apply directly through Clarivate's website or reach out to the recruitment team.