Pharmacovigilance Consulting services are provided by experienced and capable Project Managers (PMs) with excellent communication skills and robust management/organisational skills who will act as the key contact point of their assigned clients. Through regular teleconferences and frequent interaction, we aim to establish good relationships with our clients. Full transparency will be achieved by monthly reports on the project status.
- FHS consulting team has many years of experience of conducting pharmacovigilance audits worldwide and develop programmes with client companies to ensure that all elements of their pharmacovigilance system are appropriately covered.
- The team can audit Pharmacovigilance Operations at headquarter, national affiliate, distributor and partner level, with follow-up audits if required to ensure corrective measures are completed appropriately.
- Pharmacovigilance audits are an essential component of any pharmaceutical company’s Quality Management System. If carried out correctly, auditing provides an unbiased opinion of operational performance of the Pharmacovigilance system, measuring the system against its own procedures and against the regulatory guidelines, and ensuring that the system itself remains compliant with the regulations.
- Our consultants have been writing compliant SOPs for many years for a diverse range of companies and medicinal products and processes. No matter what size and shape your company is, your SOPs are all controlled, comprehensive and specific.
- We recommend expert advice at every step of your SOP journey. The process of creating and reviewing SOPs is ongoing: drafting, reviewing, approving, training, implementation and periodic review are all part of the overall process. They are audited and inspected as part of a pharmacovigilance system.
- Our consultants have been extensively involved in interpreting inspection and audit findings and can pitch the response at the appropriate level.
- The implementation of a corrective and preventive action plan can be challenging in the extreme, and expert advice and support can make the difference between a vicious cycle of repeated inspections (or worse) and a rapidly achievable compliant system that is acceptable to auditors and inspectors.
- Whether you require aggregate report training, risk management workshops, Pharmacoepidemiology support, or other types of training, we can help.
- FHS consultants have trained company employees in many countries on basic and advanced aspects of pharmacovigilance.
- Our team members have lectured on regulatory compliance and risk management as well as offering training on MedDRA® at all levels. They have been instrumental in writing the guidelines, using what they teach as part of their daily work.
- o They have lectured on these subjects at academic institutions, published papers and spoken at international conferences on all these subjects: these are people passionate about their subject.