About
We are a physician founded and run medical consulting company that provides pharmacovigilance services to biotech and pharma companies with the ultimate aim of serving patient safety and well-being.
Pharmacovigilance Physicians offers specialized drug safety, regulatory affairs, and clinical services across all therapeutic areas. Partner with the #1 pharmacovigilance services provider in the industry.
A Passion for Drug Safety
At PV Physicians we believe in process excellence and an unwavering commitment to quality. We deliver on this promise through our domain expertise and industry-unique Engagement Management model:
- Local (on-site or nearby) engagement managers with minimum 5+ years PV operations experience, lead all customer engagements
- PV Physicians engagement managers coordinate activities with the delivery teams to ensure a smooth experience and provide you with a single point of contact in your time zone
- High-quality PV, regulatory and QPPV services from experienced safety and regulatory professionals:
- All 1000 operations employees worldwide are Healthcare Professionals (HCPs)
- Delivery teams are fully dedicated to each client with each team having a “buffer” to account for scalability
- Industry-leading personnel retention in delivery center locations
- Proven ability to process high case volumes and manage volume fluctuations
- Rigorous quality standards supported by daily metrics
- System-agnostic Pharmacovigilance-as-a-Service (PVaaS), cloud hosting and Argus/ARIS excellence
REGULATORY AFFAIRS & CLINICAL:
- Global Submissions
- Regulatory Medical and Technical Writing
- eCTD Services
- Core Labeling Services
- XEVMPD Services
- Risk Management (RMP/REMS)
- Lifecycle Management
DRUGS SAFETY:
- ICSR – Case Processing (1M cases annually)
- Safety Call Center
- ICSR Submissions
- Literature Surveillance
- Aggregate Reporting Services
- Signal Management
- Risk Management Plans
- QPPV Services
- Consultancy
PV PHysicians Safety Services provide drug safety and pharmacovigilance services to small, mid and large sized pharmaceutical and biotechnology companies.
Our technology tools aim to address our clients’ pain points and act as process accelerators, providing a validated, one-stop shop solution for clients.
PV Physicians Regulatory Affairs Services provides assistance throughout the development, approval, and post-approval stages of a product’s lifecycle.