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Medical Writer Ii/Iii (Aggregate Report Experience Required)

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: Medical Writer II/III

Company Description: PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. We have achieved consistent global growth, with staff across Europe, North America, and Asia, providing services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance. We support a diverse range of pharmaceutical and biotechnology partners, from small startups to large companies, maintaining long-term relationships and leading the way in the global pharmacovigilance sector.

We invest heavily in our staff, offering robust training and development opportunities. We prioritize employee well-being, mental health, and work-life balance, recognizing that these factors are essential to delivering high-quality client service.

Join us on our journey to make a meaningful impact on patient lives!

Job Description: PrimeVigilance is seeking a Medical Writer II/III to contribute to our pharmacovigilance efforts. This is an excellent opportunity to advance your career in the drug safety field, with a focus on regulatory and clinical documentation.

Key Responsibilities:

  • Independently author, edit, and review a variety of regulatory and clinical documents (e.g., aggregate reports, risk management plans, and other product lifecycle documents) ensuring high quality and compliance with internal and external standards.
  • Actively participate in training, the development of quality system documents, and the implementation of standardized documentation templates and formats for medical writing.
  • Support pharmacovigilance operations related to medical writing.
  • Engage in continuous self-education on all aspects of medical writing.

Qualifications:

  • Previous experience in pharmacovigilance medical writing, including PBRERs, DSURs, and RMPs.
  • A background as a pharmacist, MD, or in life sciences.
  • Strong ability to manage multiple tasks, prioritize effectively, and maintain attention to detail.
  • Experience in training and mentoring Associate Medical Writers.
  • Advanced proficiency in English.

Why Join PrimeVigilance? We are dedicated to creating a workplace that fosters diversity, equity, and inclusion. At PrimeVigilance, we believe that our people are our greatest strength, and our collaborative, human-first approach drives our continued success in improving patients' lives.

We Offer:

  • Internal training and career development opportunities.
  • Strong emphasis on personal and professional growth.
  • A friendly and supportive work environment.
  • The opportunity to collaborate with colleagues from around the world, with English as the primary company language.

If our values resonate with you, PrimeVigilance could be the perfect fit for your career. Join us in making a positive impact on patient lives. We look forward to receiving your application!