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Medical Reviewer I

2+ years
Not Disclosed
10 Nov. 19, 2024
Job Description
Job Type: Full Time Remote 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

Company Description: PrimeVigilance, a part of Ergomed PLC, is a specialized mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved consistent global organic growth, with our teams located across Europe, North America, and Asia. Our expertise spans across Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

We offer first-class support to pharmaceutical and biotechnology partners of all sizes, building long-lasting relationships and becoming a leader in our field. Our service covers all therapy areas, including medical devices.

At PrimeVigilance, we prioritize employee development by offering excellent training and development platforms. We value the well-being, mental health, and work-life balance of our employees, as these contribute to both their satisfaction and the high-quality service we provide to our clients.

Job Description: We are looking for a qualified Pharmacovigilance Physician to join our team. The role involves reviewing and approving post-marketing Individual Case Safety Reports (ICSRs) and Serious Adverse Event (SAE) reports for medical/causality assessments.

Key Responsibilities:

  • Review and approve post-marketing ICSRs and SAE reports, including coding, seriousness assessment, listedness/expectedness, and company causality. This includes writing company comments, follow-up questions, and conducting Analysis of Similar Events when required.
  • Review literature screening strategies and analyze articles to determine whether they contain ICSRs/SAEs related to relevant medicinal products or other safety findings.
  • Review database outputs and provide input on Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs).
  • Participate in signal detection activities, including meetings and the writing of signal detection reports.
  • Propose actions when potential safety signals are identified.

Qualifications:

  • Medically qualified physician with experience in pharmacovigilance.
  • Experience in aggregate reports and signal detection is desirable.
  • Excellent interpersonal, communication, and presentation skills.
  • Ability to plan, organize, prioritize, and manage multiple tasks efficiently.
  • Ability to work effectively across cultures and functions, valuing teamwork.

Why Join PrimeVigilance? At PrimeVigilance, we prioritize diversity, equity, and inclusion, fostering a human-centric workplace where individuals of all backgrounds, genders, and ages can thrive. We believe our people are our greatest strength and that a collaborative, human-first approach drives our success and contributes to improving patient lives.

We Offer:

  • Internal training and career development opportunities.
  • Strong focus on personal and professional growth.
  • A friendly and supportive working environment.
  • An opportunity to work with colleagues globally, with English as the company language.

If our core values resonate with you, PrimeVigilance could be a great place to build your career. Join us on this exciting journey to make a positive impact on patients' lives. We look forward to welcoming your application!