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.
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