Medical Writing Job at PrimeVigilance | Apply Now
Looking for a rewarding medical writing job in the pharmacovigilance domain? PrimeVigilance is hiring a PV Medical Writer II in Pune, India, with flexible remote work options. This opportunity is ideal for MD professionals seeking to grow in a globally recognized CRO environment. Explore how this role combines scientific expertise, regulatory writing, and career growth within one of the leading primevigilance careers pathways.
Job Details
- Job Position: PV Medical Writer II
- Location: Pune, Maharashtra, India
- Department: Medical Writing
- Job Type: Full-time
About the Company
PrimeVigilance (part of Ergomed Group) is a specialised mid-size pharmacovigilance service provider initially established in 2008. The company has achieved consistent global organic growth, with staff across Europe, North America, and Asia. It delivers services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance.
Known for building long-term partnerships with pharmaceutical and biotechnology companies, PrimeVigilance has become a global leader across therapy areas, including medical devices. As part of primevigilance careers, employees benefit from strong training programs, career development opportunities, and a supportive work environment focused on well-being and work-life balance.
Job Description
This medical writing job focuses on pharmacovigilance documentation and regulatory writing. The Medical Writer will be responsible for preparing and reviewing key aggregate safety reports and supporting project timelines. Key deliverables include:
- PSURs/PBRERs
- PADERs
- ACOs
- DSURs
- RMPs
The role also involves quality control (QC) and review of written outputs, supporting project managers in scheduling reports, and ensuring compliance with SOPs and templates. In addition, the candidate will:
- Complete quality documentation of aggregate reports
- Attend client kick-off meetings
- Participate in audits and inspections
- Provide aggregate report training
Qualifications
- MD
- Strong experience in Pharmacovigilance (case processing, signal detection, or risk management), preferably in a CRO environment
- Ability to manage multiple tasks with attention to detail
- Strong mentoring and training capabilities
- Excellent teamwork skills
- Fluency in English (additional languages are a plus)
Key Responsibilities
- Perform medical writing for pharmacovigilance reports
- Conduct QC and review of aggregate safety documents
- Support scheduling and planning of report submissions
- Identify improvement areas with Quality and Compliance teams
- Assist in training Associate Medical Writers
- Participate in audits, inspections, and client meetings
- Maintain high-quality documentation standards
