PrimeVigilance Hiring for Senior Medical Writer with line management experience. Opportunity for experienced PV writers to lead teams and develop regulatory documents.
PrimeVigilance, a globally recognized pharmacovigilance and medical information service provider under the Ergomed Group, is inviting applications for the role of Senior Medical Writer with line management experience. This full-time opportunity, based in Bengaluru with remote flexibility, is ideal for experienced medical writing professionals eager to advance their careers in drug safety, regulatory documentation, and team leadership. PrimeVigilance Hiring for Senior Medical Writer
PrimeVigilance has built a strong reputation since its establishment in 2008, growing organically year after year and expanding its global workforce across Europe, North America, and Asia. The company provides services across Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance for pharmaceutical, biotechnology, and medical device organizations. The Senior Medical Writer role offers a unique opportunity to strengthen scientific writing capabilities while contributing to global patient safety. PrimeVigilance Hiring for Senior Medical Writer
This post outlines role expectations, responsibilities, required qualifications, organizational culture, benefits, and clear instructions on how to apply.
Key Highlights – Senior Medical Writer Recruitment
| Category | Details |
|---|---|
| Position | Senior Medical Writer |
| Required Experience | Medical writing + pharmacovigilance experience + line management |
| Department | Medical Writing |
| Location | Bengaluru, Karnataka (Remote eligible) |
| Job Type | Full-Time |
| Industry | Pharmacovigilance, Drug Safety, Regulatory Writing |
| Company | PrimeVigilance (Ergomed Group) |
| Education | Life Science / Nursing / Medical degree |
About PrimeVigilance
PrimeVigilance is a specialized mid-size pharmacovigilance service provider that has grown significantly since 2008. The company supports pharmaceutical and biotechnology partners of all sizes, delivering high-quality pharmacovigilance operations across the entire product life cycle. PrimeVigilance Hiring for Senior Medical Writer
With staff located across multiple continents, PrimeVigilance has built a global reputation for:
- Strong scientific expertise
- End-to-end pharmacovigilance support
- Regulatory compliance excellence
- Long-term client partnerships
- Diversified experience across all therapy areas, including medical devices
The organization is passionately employee-centric, focusing on professional development, well-being, training, and work-life balance. PrimeVigilance believes that a healthy, well-supported workforce delivers superior client outcomes and contributes meaningfully to improving patient lives worldwide. PrimeVigilance Hiring for Senior Medical Writer
Role Overview – Senior Medical Writer
The Senior Medical Writer plays a critical role in the development, review, and quality management of regulatory and safety documents required throughout a product’s life cycle. The position requires strong scientific writing abilities, leadership experience, team management skills, and deep understanding of pharmacovigilance processes. PrimeVigilance Hiring for Senior Medical Writer
This role is suited for professionals who have previously authored documents such as PBRERs, DSURs, RMPs, and other aggregate safety reports. In addition to writing responsibilities, the Senior Medical Writer will supervise junior writers, review their work, and support their professional development. PrimeVigilance Hiring for Senior Medical Writer
The position provides exposure to diverse therapeutic areas, regulatory submissions, and complex safety document development, making it an excellent opportunity for growth in advanced medical writing and PV operations. PrimeVigilance Hiring for Senior Medical Writer
Detailed Responsibilities
The Senior Medical Writer will handle a wide range of responsibilities involving document authorship, compliance oversight, quality control, and team leadership. PrimeVigilance Hiring for Senior Medical Writer
1. Independent Authoring of Regulatory and Clinical Documents
The role requires drafting, editing, and reviewing regulatory and safety documents needed at various stages of the product life cycle. These may include: PrimeVigilance Hiring for Senior Medical Writer
- Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Development Safety Update Reports (DSURs)
- Risk Management Plans (RMPs)
- Aggregate safety reports
- Other post-marketing and clinical regulatory documents
The writer is responsible for document quality, accuracy, structure, and adherence to internal templates and global regulatory standards. PrimeVigilance Hiring for Senior Medical Writer
2. Review and Quality Control of Written Deliverables
The Senior Medical Writer must ensure that every assigned document meets the highest standards of clarity, consistency, scientific accuracy, and traceability. This includes performing detailed quality checks and ensuring compliance with ICH, GVP, and client requirements.
3. Contribution to Development and Maintenance of Internal Quality Systems
The role includes supporting internal quality system activities such as:
- Updating templates and formats
- Developing standardized writing frameworks
- Implementing improvements in medical writing processes
- Participating in internal audits and compliance checks
This ensures that PrimeVigilance continues to deliver documents that meet regulatory scrutiny. PrimeVigilance Hiring for Senior Medical Writer
4. Supporting Pharmacovigilance Operations
In addition to writing responsibilities, the Senior Medical Writer contributes to various PV-related activities, supporting colleagues in safety surveillance, quality compliance, and document workflows.
5. Continuous Self-Learning and Skill Development
PrimeVigilance encourages employees to enhance their knowledge in:
- Global pharmacovigilance regulations
- Scientific literature interpretation
- Evolving regulatory writing standards
- New safety risk management concepts
Continuous improvement is a core expectation for all scientific roles.
6. Managing and Mentoring Junior Medical Writers
A key requirement for this role is line management experience. Responsibilities include:
- Supervising and guiding junior writers
- Conducting document reviews and providing constructive feedback
- Training associates on templates, regulatory requirements, and writing best practices
- Monitoring progress and supporting performance development
Strong leadership skills are essential for fostering team growth and ensuring high-quality deliverables. PrimeVigilance Hiring for Senior Medical Writer
Qualifications and Skills Required
PrimeVigilance is looking for dedicated professionals with the following qualifications: PrimeVigilance Hiring for Senior Medical Writer
Educational Requirements
- Degree in Life Sciences
- Nursing qualification
- Medical qualification
- Or equivalent scientific background
Experience Requirements
- Prior experience in pharmacovigilance medical writing
- Hands-on experience writing PBRERs, DSURs, RMPs, and similar regulatory documents
- Experience in mentoring or managing junior writers
- Strong understanding of safety regulations and document structure
Technical and Soft Skills
- Excellent English writing and editing abilities
- Strong attention to detail and scientific accuracy
- Ability to manage multiple projects and prioritize effectively
- Capability to mentor and train team members
- Strong communication and interpersonal skills
- Collaborative mindset for working with global teams
Why Join PrimeVigilance?
PrimeVigilance emphasizes a supportive, inclusive, and globally collaborative work culture. Employees benefit from career growth pathways, well-being initiatives, and exposure to challenging and rewarding projects. PrimeVigilance Hiring for Senior Medical Writer
Key Benefits
- Comprehensive internal training programs
- Clear career development plans
- Supportive and friendly working environment
- Opportunity to collaborate with teams across the globe
- English is the primary language of communication
- Emphasis on work-life balance and mental well-being
Core Values at PrimeVigilance
The organization operates based on principles that define its culture: PrimeVigilance Hiring for Senior Medical Writer
- Quality
- Integrity and Trust
- Drive and Passion
- Agility and Responsiveness
- Belonging
- Collaborative Partnerships
Employees who resonate with these values thrive in the PrimeVigilance work environment.
How to Apply for Senior Medical Writer – PrimeVigilance
Candidates interested in this position can apply through the official PrimeVigilance careers portal. PrimeVigilance Hiring for Senior Medical Writer
Application Instructions:
- Visit the PrimeVigilance Careers Page.
- Search for Senior Medical Writer (Line Management Experience Required) – Bengaluru.
- Submit your updated resume and complete the application form.
- Highlight your medical writing experience, pharmacovigilance background, and team leadership responsibilities in your CV.
Shortlisted candidates will be contacted directly by the recruitment team. PrimeVigilance Hiring for Senior Medical Writer
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