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Senior Medical Writer I (Line Management Experience Required)

0-2 years
Not Disclosed
10 Nov. 14, 2025
Job Description
Job Type: Full Time 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

Senior Medical Writer I (Line Management Experience Required)

Location: Sofia, Bulgaria
Employment Type: Full-time
Department: Medical Writing
Company: PrimeVigilance (Ergomed Group)


Company Overview

PrimeVigilance, founded in 2008, is a specialized global pharmacovigilance service provider and part of the Ergomed Group. With teams across Europe, North America, and Asia, we support pharmaceutical and biotechnology companies of all sizes in:

  • Medical Information

  • Pharmacovigilance

  • Regulatory Affairs

  • Quality Assurance

We offer a strong employee-centered culture focused on training, development, mental health, and work–life balance. PrimeVigilance is recognized globally for excellence and long-term partnerships.


Role Summary

The Senior Medical Writer I plays a key role in drug safety documentation by independently creating and reviewing high-quality regulatory documents. The role also includes training, team leadership, and contribution to departmental growth.


Key Responsibilities

Regulatory & Clinical Writing

  • Independently author, edit, and review PV and regulatory documents such as:

    • DSURs

    • PSURs

    • RMPs

    • ACOs

    • Other documents across the product lifecycle

  • Ensure documents meet internal quality standards and external regulatory requirements.

Quality Systems & Templates

  • Participate in training and ongoing development.

  • Support creation, implementation, and updating of:

    • SOPs

    • Quality system documentation

    • Standard templates and formats

Pharmacovigilance Operations

  • Provide support in all PV activities linked to medical writing.

Team Leadership

  • Manage, mentor, and oversee junior medical writers.

Continuous Learning

  • Engage in self-development related to medical writing, pharmacovigilance, and regulatory requirements.


Qualifications

Education

  • Life Science degree required.

  • Masters or PhD preferred.

Experience

  • Strong experience in pharmacovigilance aggregate report writing:

    • DSUR, PSUR, RMP, ACO, etc.

  • Experience in a CRO or PV service provider environment preferred.

  • Mandatory: Line management or team leadership experience.

Skills

  • Excellent written and verbal communication skills in English.

  • Additional language proficiency is an advantage.


Why Join PrimeVigilance?

Our Culture

PrimeVigilance prioritizes:

  • Diversity & inclusion

  • Human-first work environment

  • Equal opportunity

  • Professional growth and mentorship

What We Offer

  • Extensive training and professional development

  • Opportunities for career progression

  • Friendly, collaborative work environment

  • Global exposure—teams across multiple continents

  • Clear alignment with core values:

    • Quality

    • Integrity & Trust

    • Drive & Passion

    • Agility & Responsiveness

    • Belonging

    • Collaborative Partnerships