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Senior Medical Writer (Line Management Experience Required)

0-2 years
Not Disclosed
10 Oct. 13, 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

Job Title: Senior Medical Writer (Line Management Experience Required)

Location: Delhi, India
Employment Type: Full-Time
Department: Medical Writing
Company: PrimeVigilance (part of Ergomed Group)


Company Overview

PrimeVigilance, established in 2008, is a mid-size global pharmacovigilance service provider with teams across Europe, North America, and Asia. The company specializes in:

  • Medical Information

  • Pharmacovigilance

  • Regulatory Affairs

  • Quality Assurance

PrimeVigilance serves pharmaceutical and biotechnology partners across all therapy areas, including medical devices. The company emphasizes employee training, development, well-being, and work-life balance to maintain high-quality client services.


Purpose of the Role

The Senior Medical Writer will be responsible for leading medical writing activities, ensuring quality and compliance of regulatory documents, and managing a team of junior writers. This role offers an opportunity to further develop expertise in pharmacovigilance and contribute to patient safety.


Key Responsibilities

Medical Writing & Documentation

  • Independently author, edit, and review regulatory/clinical documents, including:

    • Aggregate Reports (PSURs/PBRERs)

    • Risk Management Plans (RMPs)

    • DSURs

    • Other documents throughout the product life cycle

  • Ensure documents meet quality standards and comply with internal and external regulations.

  • Participate in the development, implementation, and maintenance of medical writing quality system documents, including internal templates and formats.

Operational Support

  • Support pharmacovigilance operations associated with medical writing.

  • Continuously update knowledge in medical writing practices and regulatory requirements.

Team Leadership

  • Manage and mentor a team of junior medical writers.

  • Provide training and guidance to associates to ensure quality and compliance.


Qualifications & Experience

  • Life Sciences degree, or equivalent nursing/medical qualifications.

  • Previous experience in pharmacovigilance medical writing (PBRERs, DSURs, RMPs).

  • Ability to manage multiple tasks and prioritize workload with attention to detail.

  • Strong mentoring and training capabilities for Associate Medical Writers.

  • Advanced English proficiency.


Company Culture & Additional Information

  • PrimeVigilance promotes diversity, equity, and inclusion in a human-centric environment.

  • Offers training and career development, personal and professional growth opportunities.

  • Friendly, supportive, and collaborative work environment.

  • Opportunity to work with colleagues globally, with English as the company language.

Core Values:

  • Quality

  • Integrity & Trust

  • Drive & Passion

  • Agility & Responsiveness

  • Belonging

  • Collaborative Partnerships

This role allows you to contribute to high-quality pharmacovigilance outputs and positively impact patients’ lives.