PharmaCons PhVC
Pharmacons PHVC SRL specializes in pharmacovigilance and drug safety services, providing expert support in safety data management, signal detection, safety evaluation reports, and pharmacovigilance system support. Their mission is to ensure patient safety through robust pharmacovigilance systems, resource flexibility, and expert medical review, aiming to improve drug safety monitoring and compliance with global regulatory standards.
Industries
Nr. of Employees
small (1-50)
PharmaCons PhVC
Bucharest, Bucuresti, Romania, Europe
Services
Remote or client-database-based processing of individual adverse event cases from clinical trials, post-marketing sources and literature, including coding, medical review, follow-up and quality control.
Identification and evaluation of potential safety signals from multiple data sources to support benefit–risk assessment and regulatory reporting.
Preparation of periodic safety update reports, periodic benefit-risk evaluation reports, risk management plans and clinical evaluation summaries as required for regulatory compliance.
Development and oversight of agreements that define safety data exchange workflows and responsibilities between commercial parties.
Preparation and ongoing maintenance of the Pharmacovigilance System Master File documenting PV system structure, roles, processes and compliance artefacts.
Provision of specialist personnel (medical reviewers, case processors, project managers) and managed teams to support or replace in-house PV activities.
Remote or client-database-based processing of individual adverse event cases from clinical trials, post-marketing sources and literature, including coding, medical review, follow-up and quality control.
Identification and evaluation of potential safety signals from multiple data sources to support benefit–risk assessment and regulatory reporting.
Preparation of periodic safety update reports, periodic benefit-risk evaluation reports, risk management plans and clinical evaluation summaries as required for regulatory compliance.
Development and oversight of agreements that define safety data exchange workflows and responsibilities between commercial parties.
Preparation and ongoing maintenance of the Pharmacovigilance System Master File documenting PV system structure, roles, processes and compliance artefacts.
Provision of specialist personnel (medical reviewers, case processors, project managers) and managed teams to support or replace in-house PV activities.
Expertise Areas
- Pharmacovigilance and drug safety
- Adverse event case processing
- Signal detection and safety surveillance
- Aggregate safety reporting and risk management
Key Technologies
- Pharmacovigilance case management databases
- MedDRA coding
- Signal detection methodologies
- Aggregate safety reporting workflows