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.
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