Consultancy Services for Pharmacovigilance

Since the Pharmaceutical Drug Law Novelle came into force in the recent years, the monitoring of drug safety via Pharmacovigilance System has been progressively formalized. Closed timelines and complex regulatory requirements demand increased number of qualified personnel. To meet the formal requirements, we provide the following services:

• Developing and improving of best practice methods, Standard Operating Procedures and Guidance Documents for Pharmacovigilance
• Establishing of appropriate database structures to optimize contract management systems (collection and monitoring of PVAs worldwide for storage in a central database)
• Preparation and support of Audits and Inspections, Corrective Action / Preventive Action (CAPA) Management
• Review and attend all code lists, product dictionaries and reference data used in the GPV IT systems, (eg MedDRA) as a prerequisite for the automatic classification of Adverse Events
• Investigation and monitoring of study information, deployment and updating of relevant Study-Setups in the GPV IT systems regarding the current regulations (GVP modules) and preparation for upcoming regulations (IDMP)
• Investigation of product-specific reporting obligations to national regulatory authorities and license partners
• Creation, handling and monitoring of Pharmacovigilance agreements (PVA’s) with external partners such as License partner or CRO's
• Optimization of business processes regarding the risk management of generating of reports that are requested by health authorities
• Ensure the compliant cooperation with external partners