We provide pharmacovigilance (PV) services for pharmaceutical companies, from literature monitoring to case processing. We also provide consultancy for pharmacovigilance services. Our services include setting up of complete pharmacovigilance unit, PV voice process support, end-to-end case processing, aggregate report writing, safety report writing, literature search services, PV training, PV auditing and inspection support, and any strategic support for PV-related matters.
Pharmacovigilance deals with collection, detection, evaluation, and monitoring of adverse events observed with any pharmaceutical product. Information is collected from the patients, healthcare providers or medical literature which plays a critical role in providing data for pharmacovigilance. All the collected data is submitted to the regulatory authorities for assessing the risk-benefit profile of any pharmaceutical product, thereby enhancing patient care and patient safety.
Turacoz provides support for pharmacovigilance activities at all the steps from literature monitoring to case processing. We also provide consultancy for pharmacovigilance services. Our services can be categorized as following:
- Setting up of a complete, comprehensive & robust pharmacovigilance unit
- Pharmacovigilance voice process support
- SOP and procedural document development (per relevant guidelines)
- End-to-end case processing expertise for clinical trial cases and post-marketed products
- Aggregate report writing
- Periodic Safety Update Report (PSUR)/Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Adverse Drug Experience Report (PADER)
- Development Safety Update Report (DSUR)
- Safety report writing
- Safety narratives
- Risk Management Plan (RMP)/Risk Evaluation and Mitigation Strategy (REMS)
- Literature search services for adverse events reporting
- Continuous signal detection, evaluation, and management
- Development of PV System Master File (PSMF) or Detailed Description of Pharmacovigilance System (DDPS)
- Pharmacovigilance training: both onsite and e-learning
- Pharmacovigilance auditing and inspection support
- Procedural/operational gap assessment and correction in the PV systems and procedures
- Continuous benefit-risk evaluation and management throughout the product life cycle
- Responding to health/ regulatory authority queries
- Strategic support for any pharmacovigilance matter viz. in mergers and acquisitions (M&As), due diligence in small, mid or large sized M&As, safety database selection, data migration and integration of PV safety databases.