Pharmacovigilance services refers to the activities and processes involved in monitoring, detecting, assessing, and preventing adverse effects or any other drug-related problems associated with the use of medications or medical products. Pharmacovigilance is crucial for ensuring the safety of drugs and medical devices throughout their lifecycle, from development to post-marketing surveillance.
PharmOut’s pharmacovigilance services offering is supported a team of well trained and experienced pharmacovigilance professionals and a range of regulatory, GMP and design professionals, offering a one-stop shop of support services. The team uses a risk-based approach to focus scarce resources on critical to product quality and patient safety matters.
Whether it is an existing facility, or a brand new facility manufacturing pharmaceuticals, medical devices or biologics; our consultants can navigate their way through the regulations and help you set up a compliant system in which you can have confidence.
When you need ‘hands on deck’ to do the work associated with pharmacovigilance program or systems, we have many capable and professional contractors to choose from.
Pharmacovigilance and Device Vigilance Services
Navigating the Complexities – Choosing the Perfect Partner for Your Needs in Australia and New Zealand
Selecting the right Pharmacovigilance (PV), Medical Information (MI), and Device Vigilance partner for a range of registered or listed products is a delicate process. Initially, one must prioritise experience, quality, efficiency, and compliance—fundamental elements evident in every successful program.
Beyond this, it’s essential to gauge the provider’s adaptability to the unique needs and bespoke requests, especially when aligning with specific Australian or New Zealand regulatory requirements.
An essential aspect of this selection process is evaluating the cultural alignment and compatibility for a lasting partnership. Feeling understood, communicating seamlessly, and receiving comprehensive and prompt help are all essential. True success in partnering with the ideal pharmacovigilance ally goes beyond surface interactions—it’s about their constant and proactive approach.
Do they proactively expect that they might be called upon to facilitate and assist with urgent requests? Are they agile in responding to regulatory engagements? Do they consistently offer innovative solutions? Are they abreast of impending regulatory shifts and their potential impact on your projects? And, crucially, do they provide cost-effective solutions?
Engage with PharmOut. Experience our commitment to treating every client’s project as our singular focus.
The World Health Organisation (WHO) defines pharmacovigilance as ‘the science and activities concerning the detection, assessment, comprehension, and prevention of adverse effects and other medicine-related issues’. It plays a pivotal role in ensuring the safety of drugs and medical devices, spanning from their development phase to post-marketing surveillance.
Post-marketing pharmacovigilance programs demand a tailored approach. Regulatory requirements can vary significantly. Collaborations with business partners might necessitate the formulation and maintenance of safety data exchange (SDEAs) or PV agreements (PVA).
As a premier Australian entity, PharmOut recognises the paramount importance of patient safety, from clinical trials to the post-marketing surveillance of medicinal products. Our safety services portfolio offers a diverse range of Pharmacovigilance and Vigilance Services for sponsors in Australia and New Zealand, and international clients.
PharmOut’s Pharmacovigilance Services Portfolio Comprises:
- Pharmacovigilance Consulting
- Receipt, Triage, Processing, and Submission of Individual Case Safety Reports (ICSRs)
- Drafting of Australian Specific Risk Management Plans, Consumer Medicine Information, and Product Information
- Assistance with Post-Authorisation Safety Studies (PASS)Pharmacovigilance-related regulatory support
- Signal Management, including the identification of new safety signals or risk alterations.
- Preparation of Signal Management Trackers and Annual Signal Reports
- Medical and Scientific Literature Searches tailored for Australia and New Zealand
- Global / Database Specific Medical and Scientific Literature Searches
- Services of Australian Qualified Person of Pharmacovigilance (QPPVA) and Australian Pharmacovigilance Contact Person (A-PVCP)
- Authoring and reviewing of SDEA agreements, commercial partner agreements, and PV SOPs
- PV Audit & Compliance, PV Systems and Quality Management System Oversight
- Conducting gap assessments of PV Systems for clients or on behalf of Global Pharmacovigilance Units
- Offering bespoke training on safety-related topics
- Assisting clients with PV Inspections and audits
- Regulatory intelligence
Complementary Services to Pharmacovigilance Include:
- Medical Information
- Device Vigilance
- Product Quality Complaints
- Consultation for Unapproved Medicine Systems, such as the Special Access Scheme and Clinical Trials
- Leave Coverage
PharmOut, a leading authority in medical device vigilance and regulatory affairs organisation, emphasises the critical nature of comprehensive reporting as mandated by the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002. In Australia, medical device manufacturers and sponsors must meticulously report adverse events and recalls to the Therapeutic Goods Administration (TGA), underlining the severity of compliance in this domain.
Informed by the Australian Regulatory Guidelines for Medical Devices (ARGMD), PharmOut provides detailed guidance on the nuances of vigilance reporting, encompassing terminology, timelines, and other pivotal aspects. For international entities, PharmOut is a crucial partner for sponsors, bridging the gap with the TGA and ensuring the reporting of adverse events. The stakes are high, as any lapse in accurate reporting can result in substantial financial repercussions or regulatory concerns. Hence, our team underscores the importance of proactive communication with sponsors whenever vigilance reporting is necessitated.
Adverse event reporting is a critical component of our vigilance services. Recognising the gravity of occurrences that may lead to death, serious injury, or significant deterioration, including life-threatening situations, permanent impairments, or conditions requiring medical intervention, PharmOut is committed to the stringent reporting of these events, as well as ‘near adverse events,’ through the Medical Device Incident Reporting (MDIR) system to the TGA.
Choosing PharmOut as your Pharmacovigilance, Device Vigilance, and Regulatory Affairs partner in Australia means partnering with a leader in strategic compliance and vigilant regulatory support. Our team, with deep expertise in both Australian and global regulatory landscapes, excels in tailoring our services to your unique product requirements, ensuring your medical devices and pharmaceuticals are not just compliant but also set the standard for industry excellence. Our commitment to your success is reflected in our comprehensive services, ranging from meticulous adverse event reporting to strategic post-market surveillance and robust regulatory consulting. With PharmOut, you don’t just get a service provider; you gain a partner who is invested in your journey and dedicated to ensuring that every aspect of your vigilance and regulatory processes is seamless, efficient, and future proof.
If excellence in compliance, a proactive approach to regulatory shifts and a partnership that values precision and strategic foresight is what you seek, PharmOut is your indispensable ally.
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