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Pharmacovigilance Medical Writer Ii (Aggregate Report Writing Experience Required)

0-2 years
Not Disclosed
10 Nov. 14, 2025
Job Description
Job Type: Full Time Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/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

Pharmacovigilance Medical Writer II

Work Model: Remote
Department: Medical Writing
Employment Type: Full-time
Company: PrimeVigilance (Part of Ergomed PLC)


About PrimeVigilance

PrimeVigilance is a specialised mid-size pharmacovigilance service provider founded in 2008. With continuous global growth, the company has teams across Europe, North America, and Asia delivering expert services in:

  • Medical Information

  • Pharmacovigilance

  • Regulatory Affairs

  • Quality Assurance

The organisation partners with pharmaceutical and biotechnology companies of all sizes across all therapeutic areas, including medical devices. PrimeVigilance emphasises:

  • High-quality client service

  • Long-term partnerships

  • Employee training and career growth

  • Work–life balance and mental well-being


Role Overview

The Medical Writer II – Pharmacovigilance will be responsible for advanced medical writing tasks, primarily focused on aggregate safety reports. The role requires prior experience in aggregate report writing and the ability to mentor junior writers.


Key Responsibilities

Aggregate Report Writing

Preparation, review, and quality control of:

  • PSURs / PBRERs

  • PADERs

  • ACOs

  • DSURs

  • RMPs

Quality & Compliance

  • Review of outputs created by operations teams

  • Completing required quality documentation

  • Identifying opportunities for process improvement

  • Supporting updates to SOPs, Operational Guidelines, and templates

  • Providing training related to aggregate report writing

Project & Client Interaction

  • Supporting Project Managers in scheduling and planning aggregate reports

  • Participating in client kick-off meetings

  • Representing the team during audits and inspections

Leadership & Training

  • Training and mentoring Associate Medical Writers

  • Offering guidance on writing standards and regulatory expectations


Qualifications

Education

  • MD, Pharmacy, or Life Science degree

  • Master’s or PhD preferred

Experience

  • Strong prior experience in Pharmacovigilance:

    • Aggregate safety report writing (essential)

    • Case processing, signal detection, or risk management (preferred)

  • CRO experience is desirable

Skills

  • Excellent attention to detail

  • Ability to prioritise multiple tasks

  • Capability to train and guide junior writers

  • Strong teamwork and communication skills

  • Fluency in English (additional languages beneficial)


Why Join PrimeVigilance?

  • Comprehensive internal training and career development

  • Strong focus on personal and professional growth

  • Friendly, collaborative working environment

  • Opportunity to work with global colleagues (English as main company language)

  • Inclusive culture promoting diversity, equity, and belonging

Core Values

  • Quality

  • Integrity & Trust

  • Drive & Passion

  • Agility & Responsiveness

  • Belonging

  • Collaborative Partnerships