Medical Writer

1-6 years

Not Disclosed

India

10 Aug. 9, 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 Description: Medical Writer

Company: PrimeVigilance
Location: North America, Europe, or Asia

Overview:

The Medical Writer position at PrimeVigilance provides an excellent opportunity to advance your career in Pharmacovigilance Medical Writing. As a key member of our Medical Writing team, you will contribute to the preparation and review of critical documents throughout the product lifecycle.

Key Accountabilities:

Document Preparation: Author and develop Medical Writing tasks including aggregate reports, Risk Management Plans (RMPs), and other essential documents throughout the product lifecycle.
Quality Assurance: Ensure the quality and accuracy of documents, including performing quality control reviews of documents prepared by Medical Writing peers.
Continuous Learning: Engage in ongoing self-education and stay current with developments in Medical Writing activities.
Training & Development: Actively participate in training programs and contribute to the maintenance and development of quality system documents.
PV Operations Support: Provide support for all Pharmacovigilance operations related to Medical Writing.

Qualifications:

Education: PhD or MSc in Life Sciences or Healthcare (e.g., pharmacy, biology, chemistry, veterinary medicine).
Experience: Prior experience in drug safety medical writing, including preparation of PBRERs (Periodic Benefit-Risk Evaluation Reports), DSURs (Development Safety Update Reports), and RMPs (Risk Management Plans).
Skills: Strong time management, organizational, and multitasking abilities with keen attention to detail.
Communication: Excellent communication and presentation skills.
Technical Proficiency: Advanced knowledge of MS Office.
Language: Fluency in English.

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Medical Writer

Job Description

Key Accountabilities:

Qualifications:

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