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Pharmacovigilance Specialist

2+ years
Not Disclosed
10 Jan. 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Position: Pharmacovigilance Specialist
Location: Hyderabad, Telangana, India
Workplace Type: On-site
Employment Type: Full-time


Company Overview

ProPharma has been a leader in advancing health and wellness for patients for over 20 years, supporting biotech, med device, and pharmaceutical organizations with expert advice. The company partners with clients through an advise-build-operate model across the product lifecycle, specializing in regulatory sciences, clinical research, pharmacovigilance, quality & compliance, medical information, and R&D technology. ProPharma’s services de-risk and accelerate drug and device programs worldwide.


Job Responsibilities

  • Case Processing: Manage daily adverse event case processing (clinical trials and/or post-market), including coding with MedDRA and determining seriousness and expectedness at the event and case level.
  • Follow-Up Activities: Perform follow-up activities to collect necessary information for cases.
  • Case Narratives: Create and review case narratives to ensure accuracy and compliance.
  • Client Notifications: Provide client notifications as needed for case management.
  • Training: Contribute to the development and delivery of training materials.
  • Quality Control: Identify areas of concern or discrepancies related to ICSRs and escalate them to the Principal PV Specialist or Manager.
  • Regulatory Knowledge: Stay updated on global safety regulations for medicines.
  • Peer Reviews: Participate in peer reviews of cases for consistency, accuracy, and quality.
  • Additional Duties: Perform other tasks as assigned.

Necessary Skills and Abilities

  • Strong verbal, written, and interpersonal communication skills.
  • High level of attention to detail and accuracy.
  • Ability to identify and resolve problems promptly.
  • Capable of working independently as well as part of a multi-disciplinary team.
  • Excellent organizational and multitasking skills.
  • Basic knowledge of pharmacovigilance.

Educational Requirements

  • Required: Bachelor’s degree in life sciences.
  • Preferred: Advanced degree, RN, RPh, PharmD, or equivalent.

Experience Requirements

  • Minimum of 2 years of relevant work experience in pharmacovigilance or related fields.

ProPharma’s Commitment to Diversity

ProPharma celebrates diversity and strives to create an inclusive workplace where employees are empowered to be their authentic selves. The company encourages innovation, collaboration, and entrepreneurship while promoting equity and inclusion.