Pharmacovigilance


Dor Pharmaceutical Services delivers Pharmacovigilance (PV), device vigilance, medical information (MI) services to assist pharmas and device companies in compliance with applicable local regulations. These outsourced services enable companies to provide the trusted lifeline that patients and healthcare providers rely on for both marketed and clinical trial products.

The Pharmacovigilance and Device-vigilance services are provided by Dor’s sister company Medicalix which is considered the leading PV service provider in Israel.

Pharmacovigilance services include:

Qualified Person for Pharmacovigilance (QPPV)

Documentation and analysis of case data

Preparation of periodic reports, such as Periodic Safety Update Reports (PSUR) and Annual Safety Reports (ASR) and ad hoc reports

Review of PSUR reports and providing of QPPV confirmation and Expert Opinion

Signal detection and risk-benefit analyses, Patient safety and risk management support

Literature searches for case identification and reporting

Medical information services

Knowledgeable responses to healthcare provider and patient inquiries on your behalf—managed by skilled and sensitive medical professionals, which includes: Sharing product information, such as: usage, side effects, drug-drug interactions, disease applications and optimizing effectiveness Comprehensive contact center and reporting services Development of frequently asked questions (FAQ) database for company responses to medical inquiries Supporting challenging products, such as those that are complex, controversial or have not yet gained market acceptance

Training courses on PV and device vigilance regulations and procedures

Contact center

Professionally staffed call center by knowledgeable, specially trained, responsive healthcare professionals Leveraged contact methods most convenient for your target audience (phone, email, fax, etc.) Customer relationship management services


Medicalix