Pharmacovigilance Job Opportunity | PrimeVigilance | Remote Pharma Job
Looking for an exciting Pharmacovigilance Job in medical writing? This Pharma Job opportunity at PrimeVigilance offers a dynamic role as a PV Medical Writer II in Pune with remote flexibility. If you have experience in pharmacovigilance and medical writing, this is a great chance to grow your career in a globally expanding organization.
- Position: PV Medical Writer II
- Location: Pune, Maharashtra, India (Remote Available)
About the Company
PrimeVigilance is a specialized pharmacovigilance service provider and part of the Ergomed Group, established in 2008. The company has achieved consistent global growth, with a strong presence across Europe, North America, and Asia.
PrimeVigilance delivers expert services in Medical Information, Pharmacovigilance, Regulatory Affairs, and Quality Assurance, supporting pharmaceutical and biotechnology companies of all sizes. Covering all therapy areas, including medical devices, the company is recognized for building long-term partnerships and delivering high-quality solutions.
Key Responsibilities
- Medical writing for PSURs/PBRERs, PADERs, ACOs, DSURs, and RMPs
- QC and review of written outputs from the operations team
- Support project managers in scheduling aggregate reports
- Identify improvement areas with the Quality & Compliance team and support training/SOP updates
- Complete quality documentation for aggregate reports
- Participate in client kick-off meetings
- Attend audits and inspections
- Provide training on aggregate reports
Qualifications
- pharmacy degree (Master’s or PhD is desirable)
- Strong previous experience in Pharmacovigilance (case processing, signal detection, or risk management) within an ideal CRO environment
- Ability to manage multiple and varied tasks and prioritize workload with attention to detail
- Ability to effectively train and mentor Associate Medical Writers
- Must be a strong team player
- Fluency in English and an additional language is a benefit
Why Join This Role?
- Work in a globally recognized pharmacovigilance organization with strong industry reputation
- Opportunity to handle diverse aggregate reports like PSURs, DSURs, and RMPs
- Exposure to international clients and regulatory standards
- Strong focus on training, learning, and career development
- Collaborative and supportive work environment
- Involvement in audits, inspections, and client interactions
- Opportunity to mentor and train junior medical writers
