Pharmacovigilance Services – An Overview
Pharmacovigilance and drug safety is the most important functions within life sciences companies, and hence, they require expert pharmacovigilance services. Pharmacovigilance (PV), also known as drug safety pharmacovigilance, relates to two (02) major aspects of any drug formulation/medical intervention with therapeutic benefit, safety, and efficacy. The first is to know whether a drug works, and the second is to decode its safety.
The spectrum of pharmacovigilance services is majorly divided into pharmacovigilance operations, pharmacovigilance surveillance, pharmacovigilance database and systems, and Qualified Person for Pharmacovigilance (QPPV).
Often, companies choose to outsource end-to-end drug safety pharmacovigilance services from a PV specialist provider for the following two (02) reasons:
- The cost to internalize all the functions is a burden as there is no fixed number of reports coming in, which results in a shift-left approach to managing the workload.
- Internal resources need to focus on strategic initiatives over functional activities.
When choosing your safety partner, it is important that the partner is a beacon for end-to-end drug safety & pharmacovigilance services and has the experience and the skill set to handle such a huge task.
Freyr, as a comprehensive Regulatory service provider for pharmacovigilance & drug safety, has been well-established as a house of safety over the years, in line with the complete spectrum of pharmacovigilance services, which are as follows:
Pharmacovigilance Services - Freyr Capabilities
- Single point of contact for the entire range of safety services, including ICSR, aggregate reports, Qualified Person Responsible for PV (QPPV in Pharmacovigilance) services, the US agent services, signal detection & evaluation, database migration, adverse event reconciliation, local affiliate services, and any other region-specific pharmacovigilance consulting services.
- Initial submission kick-offs to the HA and handling/addressing HA queries.
- In-depth safety knowledge, perfectly integrated with the required IT capabilities.
- Expertise in ICSR case management, including case triage/book-in, case processing, narrative writing, medical review, quality control, and submissions.
- Staff with hands-on experience in handling/managing standard and customized pharmacovigilance safety databases like Aris G, Oracle Argus, Adverse Event Reporting System (AERS), FDA's AERS (FAERS), SCEPTRE, Empirica Trace, Sapphire, Clintrac, etc.
- Expertise in writing aggregate safety documents per various Health Authorities’ and submission requirements, such as Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Reports (PADERs), Annual Safety Reports (ASRs), Risk Management Programs (RMPs), Risk Evaluation and Mitigation Strategy (REMS), and any other country-specific reports.
- Expertise in setting up pharmacovigilance systems and processes such as PV database evaluation, PV database validation, harmonization, writing SOPs, and training employees per the local Regulatory requirements in various geographies.
- Experience in conducting mock audits, training on facing inspections, support in preparing Corrective and Preventive Action (CAPA), and remediation activities through pharmacovigilance consulting services.
- Extensive experience in PV process harmonization and creation of Company Core Data Sheet (CCDS) and Core Safety Information (CSI).
- Experience in tracking safety variations and Pharmacovigilance System Master File (PSMF) compliance.
- Defined processes of thorough scientific, medical, editorial, and quality control reviews.
- Timely delivery with the highest quality in ensuring pharmacovigilance and drug safety.
- Expert program and project management support to maintain compliance and provide pharmacovigilance solutions.
Pharmacovigilance Services - Freyr Advantages
- Competent clinical trial pharmacovigilance services.
- Developing tailored risk management plans.
- Expertise in clinical development pharmacovigilance.