Position: Senior Medical Writer (Line Management Experience Required)
Location: Remote (Employees can work from home)
Employment Type: Full-time
Department: Medical Writing
About the Company – PrimeVigilance (Part of Ergomed Group)
PrimeVigilance, established in 2008, is a specialized mid-size pharmacovigilance service provider and part of the Ergomed Group. We have achieved consistent global organic growth, with staff across Europe, North America, and Asia, offering services in:
Medical Information
Pharmacovigilance
Regulatory Affairs
Quality Assurance
We partner with pharmaceutical and biotechnology companies of all sizes, maintaining long-term relationships and delivering high-quality, compliant solutions across all therapeutic areas, including medical devices.
At PrimeVigilance, we:
Invest in our people through training and development programs
Prioritize employee well-being and mental health
Promote a healthy work-life balance, which drives both employee satisfaction and client service excellence
Join us on our journey to make a positive impact on patients’ lives.
Position Overview
The Senior Medical Writer role offers a unique opportunity to advance your career in drug safety by contributing to high-quality medical and regulatory documentation. The position also includes line management responsibilities for junior writers.
Key Responsibilities
Author, edit, and review regulatory and clinical documents independently, including:
Aggregate reports (PBRERs, DSURs)
Risk Management Plans (RMPs)
Other lifecycle-related safety and regulatory documents
Ensure accuracy, quality, and compliance of all documents with internal and external standards
Participate actively in training and process improvement activities, including the creation and maintenance of:
Quality system documents
Internal templates and standardized formats
Support pharmacovigilance operations related to medical writing
Commit to continuous professional development in all aspects of medical writing
Manage, mentor, and train a team of junior/associate medical writers
Required Qualifications
Proven experience in pharmacovigilance medical writing, including preparation of:
PBRERs
DSURs
RMPs
Bachelor’s or Master’s degree in Life Sciences, Nursing, or Medical discipline (or equivalent qualification)
Strong ability to manage multiple priorities and deliver high-quality work under deadlines
Demonstrated experience in mentoring or training junior writers
Advanced English proficiency (written and verbal)
What We Offer
Comprehensive training and career development opportunities
Strong focus on personal and professional growth
Friendly and supportive international team environment
Opportunity to work remotely with colleagues worldwide
English as the official company language
Our Core Values
Quality
Integrity & Trust
Drive & Passion
Agility & Responsiveness
Belonging
Collaborative Partnerships
Diversity, Equity & Inclusion
PrimeVigilance is committed to fostering a workplace that promotes diversity, equity, and inclusion. We celebrate individuals from all backgrounds, genders, and ages, creating a human-centric environment where everyone can thrive.
We believe our people are our greatest strength, driving our mission to improve lives through collaboration, integrity, and excellence.
Join Us
Be part of our global team and contribute to making a positive impact on patients’ lives through high-quality medical writing.
We look forward to welcoming your application!
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