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Medical Reviewer Ii

2+ years
Not Disclosed
10 Nov. 19, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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: Pharmacovigilance Physician (Qualified Person for Pharmacovigilance)

Company Description: PrimeVigilance, part of the Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. We are proud of our continuous global organic growth, with staff based across Europe, North America, and Asia. Our services cover Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. We provide exceptional support to pharmaceutical and biotechnology companies, fostering long-term relationships and establishing ourselves as global leaders in our field. We cover all therapy areas, including medical devices.

At PrimeVigilance, we invest in our employees by offering a robust training and development platform, prioritizing employee well-being and mental health, and fostering a healthy work-life balance. We believe this approach creates a high-quality work environment that enhances our ability to serve our clients.

Job Description: As a Pharmacovigilance Physician (Qualified Person for Pharmacovigilance), you will be responsible for reviewing and approving post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports in clinical trials. You will support the Qualified Person for Pharmacovigilance in evaluating safety issues and managing pharmacovigilance activities.

Main Responsibilities:

  • Review and approve ICSR and SAE reports, including coding, seriousness assessment, company causality, listedness/expectedness, and follow-up questions.
  • Act as a Qualified Person for Pharmacovigilance or support the Qualified Person in medical assessments of safety issues.
  • Provide input in Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs), and literature screening search strategies.
  • Review articles for ICSR/SAE findings related to relevant medicinal products.
  • Contribute to the preparation of Risk Management Plans and responses to regulatory authority requests.
  • Participate in signal detection activities, including reviewing line listings, writing signal detection reports, and consulting clients on benefit/risk assessment and risk minimization.
  • Evaluate and categorize potential safety signals and recommend actions.
  • Assist in the preparation and review of benefit-risk reports.

Qualifications:

  • Medical qualification as a physician.
  • Prior experience in pharmacovigilance.
  • Proficiency in reviewing aggregate reports, including PBRERs and DSURs.
  • Expertise in signal detection activities.
  • Strong interpersonal skills with the ability to work cross-culturally and cross-functionally.
  • Ability to plan, organize, prioritize, and manage multiple tasks.
  • Excellent communication and presentation skills.
  • Advanced proficiency in English (spoken and written).
  • Advanced literacy in MS Office.

Why Join PrimeVigilance? We foster an environment of diversity, equity, and inclusion, creating equal opportunities for all cultural backgrounds, genders, and ages. At PrimeVigilance, we work together with a human-first approach, recognizing that our people are the cornerstone of our success. We provide strong career development opportunities, a supportive working environment, and the chance to collaborate with colleagues worldwide.

If our core values—Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, and Collaborative Partnerships—resonate with you, we would love for you to join us.

We look forward to receiving your application!