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Senior Medical Writer (Line Management Experience Required)

0-2 years
Not Disclosed
10 Oct. 9, 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
🏢 Department: Medical Writing
🕓 Employment Type: Full-Time


🏢 Company Overview – PrimeVigilance (Part of Ergomed Group)

Founded in 2008, PrimeVigilance is a specialized mid-sized pharmacovigilance service provider within the Ergomed Group. With a strong global presence across Europe, North America, and Asia, we deliver services in:

  • Medical Information

  • Pharmacovigilance

  • Regulatory Affairs

  • Quality Assurance

We support pharmaceutical and biotechnology partners of all sizes, covering all therapeutic areas, including medical devices.

At PrimeVigilance, we believe in:

  • Investing in people through training and development.

  • Promoting employee well-being, mental health, and work-life balance.

  • Fostering an environment that ensures high-quality client service and long-term success.

Join us in our mission to make a positive impact on patients’ lives around the world.


🧾 Job Summary

This position offers an exciting opportunity to advance your career in drug safety and regulatory medical writing. As a Senior Medical Writer, you will be responsible for authoring high-quality clinical and regulatory documents while managing and mentoring a team of junior writers.


🔹 Key Responsibilities

  • Independently author, edit, and review a variety of regulatory and clinical documents (e.g., PBRERs, DSURs, RMPs, and other product lifecycle reports).

  • Ensure accuracy, consistency, and compliance with internal standards and global regulatory requirements.

  • Participate actively in training programs and contribute to the development and maintenance of medical writing SOPs, templates, and quality systems.

  • Support pharmacovigilance operations linked to medical writing.

  • Maintain continuous self-education in evolving regulatory and scientific writing practices.

  • Manage, mentor, and train a team of junior/associate medical writers to ensure deliverable quality and professional growth.


🎓 Qualifications & Experience

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

  • Bachelor’s or Master’s degree in Life Sciences (or equivalent nursing/medical qualification).

  • Demonstrated ability to manage multiple priorities with keen attention to detail.

  • Experience in mentoring or managing medical writing teams.

  • Advanced English language proficiency (written and verbal).


🌍 Diversity, Equity & Inclusion

PrimeVigilance embraces diversity, equity, and inclusion as core principles.
We strive to create a human-centric workplace where individuals from all backgrounds, cultures, and identities are respected and empowered to thrive.

Our people are our greatest strength, driving innovation and improving lives globally.


💡 What We Offer

  • Comprehensive training and career development opportunities.

  • Strong focus on personal and professional growth.

  • Friendly, collaborative, and supportive work environment.

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


💎 Our Core Values

  • Quality

  • Integrity & Trust

  • Drive & Passion

  • Agility & Responsiveness

  • Belonging

  • Collaborative Partnerships