Pharmacovigilance Medical Writer II Job at PrimeVigilance offering global PV writing, career growth, training, and supportive culture.
PrimeVigilance, a specialized pharmacovigilance service provider within the global Ergomed Group, is inviting applications for the position of Pharmacovigilance Medical Writer II for its Pune office. This long-format job post provides detailed insights into the role, responsibilities, qualifications, company background, and opportunities for professional growth. Pharmacovigilance Medical Writer II Job at PrimeVigilance
PrimeVigilance has earned a strong reputation worldwide as an industry leader in medical information, pharmacovigilance, regulatory affairs, and quality assurance. Since its establishment in 2008, the company has demonstrated consistent and sustainable global growth, expanding its team across Europe, North America, and Asia. By supporting pharmaceutical and biotechnology companies of all sizes, PrimeVigilance has built long-lasting client partnerships and established itself as a trusted specialist in drug safety and compliance. Its work spans all therapeutic areas, including medical devices, making it a highly dynamic organization within the life sciences industry. Pharmacovigilance Medical Writer II Job at PrimeVigilance
PrimeVigilance strongly believes that an organization’s success begins with its employees. Therefore, the company prioritizes a healthy work-life balance, professional development, mental well-being, and a supportive work culture. By offering excellent training opportunities, mentorship pathways, and continuous development platforms, PrimeVigilance ensures that each team member can grow personally and professionally while contributing to meaningful improvements in patient safety globally. Pharmacovigilance Medical Writer II Job at PrimeVigilance
Key Highlights of the Pharmacovigilance Medical Writer II Role
| Key Feature | Description |
|---|---|
| Job Title | Pharmacovigilance Medical Writer II |
| Location | Pune, Maharashtra, India |
| Department | Medical Writing |
| Company | PrimeVigilance (Ergomed Group) |
| Role Type | Full-time |
| Focus Areas | Aggregate reports, QC, RMPs, DSURs, PSURs |
| Required Background | MD/Pharmacy/Life Sciences with PV experience |
| Ideal Candidate | Detail-oriented, strong writing expertise, CRO experience preferred |
About PrimeVigilance
PrimeVigilance is part of the Ergomed Group and has grown from a specialized pharmacovigilance provider to one of the global leaders in drug safety and regulatory operations. Its partnerships with small, mid-size, and large pharmaceutical organizations demonstrate the trust and reliability it has built within the industry. The company’s core services include: Pharmacovigilance Medical Writer II Job at PrimeVigilance
- Pharmacovigilance
- Medical Information
- Regulatory Affairs
- Quality Assurance
Covering all therapeutic areas, PrimeVigilance ensures that clients receive high-quality, compliant, and timely safety documentation. The organization values diversity, inclusion, integrity, and agility, fostering a positive and collaborative work environment across all international teams. Pharmacovigilance Medical Writer II Job at PrimeVigilance
Detailed Role Overview: Pharmacovigilance Medical Writer II
The Pharmacovigilance Medical Writer II plays a crucial role in writing, reviewing, and delivering high-quality safety documents that comply with global regulatory requirements. This position requires strong scientific understanding, excellent writing skills, and prior experience in pharmacovigilance processes such as case processing, signal detection, or risk management. Pharmacovigilance Medical Writer II Job at PrimeVigilance
Below is a comprehensive breakdown of responsibilities associated with this role:
1. Writing of Aggregate Safety Reports
The medical writer will be responsible for preparing a wide range of pharmacovigilance aggregate reports, including:
- PSURs/PBRERs (Periodic Safety Update Reports / Periodic Benefit-Risk Evaluation Reports)
- PADERs (Periodic Adverse Drug Experience Reports)
- ACOs (Annual Safety Reports or Aggregate Company Outputs depending on project requirements)
- DSURs (Development Safety Update Reports)
- RMPs (Risk Management Plans)
These documents form the backbone of drug safety evaluation and require accuracy, comprehensive data interpretation, and consistency in scientific presentation. Pharmacovigilance Medical Writer II Job at PrimeVigilance
2. Quality Control and Review Support
The Pharmacovigilance Medical Writer II will:
- Perform QC checks of reports drafted by the operations team
- Review written outputs for clarity, consistency, compliance, and scientific accuracy
- Ensure all documents meet internal SOPs, regulatory standards, and client expectations
Maintaining high-quality deliverables is essential, as these documents are submitted to global regulatory authorities. Pharmacovigilance Medical Writer II Job at PrimeVigilance
3. Scheduling and Timeline Coordination
The writer will support project managers by:
- Helping determine timelines for delivery of aggregate reports
- Understanding project schedules and regulatory deadlines
- Coordinating with cross-functional teams to ensure on-time submission
Effective timeline management is necessary to maintain regulatory compliance and client satisfaction. Pharmacovigilance Medical Writer II Job at PrimeVigilance
4. Contribution to Quality and Training Initiatives
The role requires active collaboration with the Quality, Compliance, and Training Manager to:
- Identify areas for improving writing processes
- Support refinement of SOPs, operational guidelines, and templates
- Deliver training sessions for aggregate report writing
- Clarify procedural changes to internal teams
This ensures ongoing process improvements and standardization across the organization.
5. Participation in Client Interactions and Inspections
The writer will represent the medical writing function in:
- Client kick-off meetings
- Internal and external audits
- Inspections conducted by regulatory authorities
Professional communication and an understanding of regulatory expectations are essential for these interactions. Pharmacovigilance Medical Writer II Job at PrimeVigilance
6. Documentation and Compliance Responsibilities
The role includes:
- Completing quality documentation for all aggregate reports
- Maintaining accurate record-keeping
- Supporting compliance with global regulations and internal quality standards
These responsibilities ensure transparency and audit-readiness.
Required Qualifications
Candidates applying for the Pharmacovigilance Medical Writer II role should meet the following requirements: Pharmacovigilance Medical Writer II Job at PrimeVigilance
Educational Background
- MD, Pharmacy, or Life Science degree
- A Master’s or PhD in a relevant field is highly desirable
Experience
- Strong background in pharmacovigilance, ideally within a CRO environment
- Experience in case processing, signal detection, or risk management
- Prior experience in aggregate document writing is a significant advantage
Skills and Competencies
- Ability to prioritize and handle multiple tasks effectively
- High attention to detail and commitment to quality
- Excellent written and spoken English
- Ability to mentor Associate Medical Writers
- Strong teamwork and communication skills
- Knowledge of regulatory guidelines and PV compliance frameworks
Additional Languages
- Fluency in English is mandatory
- Additional languages are an advantage but not required
Why Join PrimeVigilance?
PrimeVigilance provides an inspiring, employee-focused environment built on trust, transparency, and opportunities for growth. Team members benefit from: Pharmacovigilance Medical Writer II Job at PrimeVigilance
- Comprehensive training and internal career development programs
- Exposure to international projects with colleagues worldwide
- A supportive, friendly workplace culture
- Opportunities to contribute to patient safety on a global scale
- An inclusive environment built on diversity, respect, and professional collaboration
The company’s core values—Quality, Integrity & Trust, Drive & Passion, Agility & Responsiveness, Belonging, and Collaborative Partnerships—shape its culture and define how teams operate.
Employees join not just for a job but for the opportunity to make a meaningful difference in improving lives. Pharmacovigilance Medical Writer II Job at PrimeVigilance
How to Apply
Candidates interested in the Pharmacovigilance Medical Writer II – Pune role can submit their application through the official PrimeVigilance careers portal. Pharmacovigilance Medical Writer II Job at PrimeVigilance
Steps to Apply:
- Visit the PrimeVigilance careers page or Ergomed Group website.
- Search for the job title: Pharmacovigilance Medical Writer II – Pune
- Submit your updated resume and complete the online application form.
- Await contact from the recruitment team regarding the next steps.
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