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Medical Writer Ii/Iii (Pharmacovigilance)- Homebased

2+ years
Not Disclosed
10 Oct. 17, 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

Medical Writer II/III (Pharmacovigilance) - Homebased

Employees can work remotely
Full-time
Department: Medical Writing

Company Description

We are PrimeVigilance, part of Ergomed PLC, a specialized mid-sized pharmacovigilance service provider established in 2008. We have achieved consistent global organic growth, with staff across Europe, North America, and Asia providing services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.

At PrimeVigilance, we offer exceptional support to our pharmaceutical and biotechnology partners, building lasting relationships and becoming leaders in the field. We cover all therapy areas, including medical devices.

We invest in our staff through a comprehensive training and development platform. We prioritize employee experience, well-being, and mental health, recognizing that a healthy work-life balance is vital for satisfaction and high-quality client service.

Job Description

The Medical Writer II/III position at PrimeVigilance presents a unique opportunity to advance your career in drug safety.

Key Responsibilities:

  • Independently author, edit, and review various regulatory and clinical documents (e.g., aggregate reports, risk management plans) ensuring quality and compliance with internal and external standards.
  • Actively participate in training and development, implementing and maintaining quality system documents for medical writing, including internal templates and formats for standardized documentation.
  • Support all pharmacovigilance operations associated with medical writing.
  • Engage in continuous self-education in all aspects of medical writing.

Qualifications

Requirements:

  • 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 and prioritize workload with attention to detail.
  • Capability to effectively train and mentor Associate Medical Writers.
  • Advanced knowledge of English.

Additional Information

Why PrimeVigilance?

We prioritize diversity, equity, and inclusion by fostering an equal-opportunity workplace where individuals from all cultural backgrounds, genders, and ages can contribute and thrive.

To succeed, we must collaborate with a human-first approach, recognizing that our people are our greatest strength in improving lives.

Our Offer:

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

If our core values resonate with you, PrimeVigilance could be the right fit!

  • Quality
  • Integrity & Trust
  • Drive & Passion
  • Agility & Responsiveness
  • Belonging
  • Collaborative Partnerships

Join us on this exciting journey to positively impact patients' lives. We look forward to welcoming your application!