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Senior Medical Writer (Line Management Experience Required)

0-2 years
Not Disclosed
10 Oct. 16, 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

Position: Senior Medical Writer (Line Management Experience Required)

Location: Hyderabad, Telangana, India
Employment Type: Full-time
Department: Medical Writing


About PrimeVigilance (Part of Ergomed Group)

PrimeVigilance is a specialized mid-size pharmacovigilance service provider, established in 2008, and recognized globally for its consistent organic growth. Our team spans Europe, North America, and Asia, delivering comprehensive services in:

  • Medical Information

  • Pharmacovigilance

  • Regulatory Affairs

  • Quality Assurance

We collaborate with pharmaceutical and biotechnology partners of all sizes, maintaining long-term relationships and providing high-quality, compliant solutions across all therapeutic areas, including medical devices.

At PrimeVigilance, we prioritize our employees through:

  • Continuous training and development programs

  • Focus on employee well-being and mental health

  • A strong commitment to work-life balance

Join us on our mission to make a positive impact on patients’ lives.


Key Responsibilities

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

    • PBRERs (Periodic Benefit-Risk Evaluation Reports)

    • DSURs (Development Safety Update Reports)

    • RMPs (Risk Management Plans)

    • Other documents across the product lifecycle

  • Ensure documents meet quality, content, and compliance standards (internal & external)

  • Participate in training sessions and contribute to the development and maintenance of quality system documents, templates, and formats

  • Support pharmacovigilance operations related to medical writing

  • Engage in continuous self-education in medical writing and regulatory science

  • Lead and manage a team of Junior Medical Writers, providing mentorship and training


Qualifications

  • Proven experience in pharmacovigilance medical writing, including PBRERs, DSURs, and RMPs

  • Life Science degree (or equivalent nursing/medical qualification)

  • Strong ability to manage multiple projects, prioritize effectively, and maintain high attention to detail

  • Experience in training and mentoring junior team members

  • Advanced proficiency in English (written and verbal)


What We Offer

  • Comprehensive training and career development opportunities

  • Strong emphasis on personal and professional growth

  • Friendly and supportive international work environment

  • Collaboration with global colleagues (English as the company language)


Our Core Values

  • Quality

  • Integrity & Trust

  • Drive & Passion

  • Agility & Responsiveness

  • Belonging

  • Collaborative Partnerships


Diversity & Inclusion

We are committed to building an equal opportunities workplace, where people from all cultural backgrounds, genders, and ages can thrive and grow. Our human-first approach recognizes that our people are our greatest strength — enabling our continued success and impact on patients’ lives.


Join us and be part of this exciting journey to make a lasting difference in healthcare.
We look forward to welcoming your application.