Reliable pharmacovigilance consulting - effective operational support
Pharmacovigilance regulatory requirements are constantly evolving. Volumes and complexity of safety data are ever-increasing. Organisational needs change over time and qualified resources are scarce. Mark Waring Pharmacovigilance Services has the expertise and experience to provide the support you need in this dynamic environment: straightforward strategic consulting on effective and compliant pharmacovigilance systems and processes, and reliable hands-on operational support with your safety data collation, evaluation and reporting needs.
Mark Waring Pharmacovigilance Services is a freelance consultancy that delivers high-quality and compliant pharmacovigilance solutions - on time and on budget. We support clinical trial sponsors with their clinical safety challenges and marketing authorisation holders of approved products. Building on 20 years of industry experience, we offer a broad range of services:
- Review and gap analysis of your pharmacovigilance system and processes.
- Conceptualisation and mapping of compliant and effective processes that are tailored to your organisation's needs.
- Preparation of corresponding system documentation: PSMF, standard operating procedures, working instructions and templates, job descriptions, training plans, etc.
- Consulting for pharmacovigilance outsourcing: support with scoping, service model and vendor selection, and contracting.
- Strategic advice on how to approach your safety question.
- Structured, systematic scientific evaluation of your pharmacovigilance data sets, both large and small.
- Literature research, review and critical appraisal.
- Full safety signal evaluation and documentation in compliance with applicable guidelines and in line with your company requirements.
- Responses to safety questions from regulatory authorities or PRAC.
- Preparation of responses to safety questions from regulatory authorities and PRAC requests.
- Benefit-risk assessments.
- Periodic data review and authorship of high-quality reports for developmental and marketed products: PSURs, PBRERs, DSURs and PADERs.
- Writing of individual sections or preparation of full, ready-to-submit reports of any size - from zero to tens of thousands of cases, in compliance with applicable regulations and guidelines such as GVP, ICH, US CFR and CIOMS.
- Authorship of protocols and reports for post authorisation safety studies (PASS)
- Consulting and operational support with labelling documents (e.g., CCDS/CCSI, SmPC).
- Strategic advice on safety risk management and RMP conceptualisation.
- Authorship of RMPs for regulatory submission in accordance with applicable regulations and guidelines.
- Conceptualisation of pharmacoepidemiological studies and post-authorisation safety studies (PASS).
- Consultancy on routine and additional risk minimisation measures.
- Guidance with risk management planning for developmental products.
- Coaching and consulting of management responsible for pharmacovigilance.
- Advanced training for pharmacovigilance staff tailored to their tasks, for example on PV regulations and requirements, clinical trial safety, ICSR evaluation, periodic reports, signal evaluation, or risk management.
- Basic pharmacovigilance training for all company staff per regulatory expectations.
Contact us to discuss your needs - we will work with you to identify the deliverables that best meet your requirements.