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3-5 years
5-7 Lacs per annum
10 Jan. 23, 2025
Job Description
Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates 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: Senior Pharmacovigilance (PV) Associate
Location: Mohali/Chandigarh
Vacancy: 01

Job Overview:
We are looking for an experienced Senior Pharmacovigilance (PV) Associate to provide technical and process-related support to drug safety management, covering both clinical trial and post-marketing activities. The role requires ensuring compliance with relevant regulations, Standard Operating Procedures (SOPs), and maintaining the highest standards of drug safety.

Key Responsibilities:

  • Provide support in drug safety management, including clinical trial and post-marketing activities, and medical monitoring.
  • Process Individual Case Safety Reports (ICSRs) from various sources.
  • Perform literature searches and reviews to support drug safety processes.
  • Detect and manage safety signals related to drug products.
  • Track regulatory information and ensure timely regulatory submissions.
  • Support the preparation of aggregate reports, study reports, and other necessary documentation.
  • Manage Medical and Product Dictionary activities as required.
  • Ensure ICSR compliance with international and local regulatory reporting requirements.
  • Conduct quality reviews of ICSRs, generate metrics, and investigate late cases.

Qualifications:

  • 3-5 years of experience in Pharmacovigilance or related fields.
  • Strong knowledge of drug safety regulations and procedures.
  • Familiarity with the preparation of regulatory submissions and signal detection processes.

Compensation:

  • Annual Salary: ₹5,00,000 - ₹7,00,000

Skills & Competencies:

  • In-depth understanding of ICSR compliance and quality review processes.
  • Ability to perform literature searches and signal detection effectively.
  • Strong communication skills and ability to generate reports.
  • Attention to detail and commitment to regulatory compliance.
  • Proficient in handling medical and product dictionaries.

How to Apply:
Interested candidates are encouraged to apply by submitting their updated resume and relevant experience details.hr@indivirtus.com with CC admin1@indivirtus.com