Ever thought what IT and PV have in common? Read this article to find out! #pharmacovigilance #PV #regulatorycompliance #PVcompliance
PharmaSpectrum Pty Ltd
Business Consulting and Services
Melbourne, VIC 217 followers
Pharmacovigilance consulting solutions for Pharmaceutical companies and CROs in Australia and New Zealand
About us
At PharmaSpectrum, we specialise in establishing Pharmacovigilance (PV) systems, providing gap analysis, acting as Qualified Person Responsible for Pharmacovigilance (QPPV), performing ICSR management, literature surveillance, signal detection, Risk Management Plan (RMP) and Periodic Safety Update Report (PSUR) writing, PV training and getting clients inspection and audit ready. We lead our Clients by the hand in the challenging world of Pharmacovigilance and Regulatory legislations and requirements. Our Clients trust us as we put Patient in the center of everything we do.
- Website
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www.pharmaspectrum.com.au
External link for PharmaSpectrum Pty Ltd
- Industry
- Business Consulting and Services
- Company size
- 2-10 employees
- Headquarters
- Melbourne, VIC
- Type
- Self-Owned
Locations
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Primary
Get directions
Melbourne, VIC, AU
Employees at PharmaSpectrum Pty Ltd
Updates
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New article about the role of the Medical Affairs department when it comes to Product Safety #pharmacovigilance #drugsafety #medicalaffairs #compliance
The Role of Medical Affairs in Pharmacovigilance
PharmaSpectrum Pty Ltd on LinkedIn
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If you have 3rd party vendors, you have to read this article! Pharmacovigilance and Medical Information service providers are not the only ones who receive safety information, so you have to have a reliable system in place to ensure receipt of relevant information from all your vendors. #pharmacovigilance #pv #compliance #vendorqualification
Vendor Qualification and Management in Pharmacovigilance: Ensuring Effective Oversight of Vendors
PharmaSpectrum Pty Ltd on LinkedIn
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Today, we are talking about the Organised Data Collection Systems. Are you sure the activities your company is performing would not fall under this umbrella? #ODCS #pharmacovigilance #PV #PVSystem #quality #compliance
Organised Data Collection Systems (ODCS) in Pharmacovigilance
PharmaSpectrum Pty Ltd on LinkedIn
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Ever wondered how QA department needs to support PV and vice versa? Find out by clicking on the short article below:
The Role of the Quality Assurance Department in Pharmacovigilance
PharmaSpectrum Pty Ltd on LinkedIn
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Even though we are approaching winter in Australia, it does not mean we are stopping the use of sunscreens. This article will help to understand why sunscreens are considered as therapeutic goods and how the TGA are regulating them.
Sunscreen Safety: Understanding TGA Regulations in Australia
PharmaSpectrum Pty Ltd on LinkedIn
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New article on why the correct Event Coding is so important and why you need a PV person residing in Australia to guide the Case Processing team residing overseas!
The importance of the correct Event Coding in Pharmacovigilance (PV)
PharmaSpectrum Pty Ltd on LinkedIn
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Check out our new article about monitoring literature surveillance in Australia. Actively tracking published literature provides a diverse and real-world perspective, uncovering new safety issues and contributing valuable data not captured in clinical trials. This proactive approach ensures regulatory compliance, supporting the continuous evaluation of a drug's benefit-risk profile and facilitating prompt risk management strategies. #literaturesurveillance #localliteraturereview #globalliteraturereview #pharmacovigilance #regulatorycompliance #pharmacovigilancecompliance
Complying to TGA's Pharmacovigilance requirements: A Guide to Global and Local Literature Surveillance
PharmaSpectrum Pty Ltd on LinkedIn
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A new article summarising PSUR requirements in Australia. Check it out if you are a Sponsor and have to perform PSUR submissions as a condition of registration. #psur #regulatorycompliance #pharmacovigilance #periodicsafetyupdatereport
Understanding PSUR Requirements in Australia: A Guide to TGA Regulations
PharmaSpectrum Pty Ltd on LinkedIn
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If you are new to RMP writing and not sure where to start, have a read of the article below and then contact us for further information on what to include in your RMP and RMM. We are here to help! #pharmacovigilance #rmp #rmm #pharmaspectrum #regulatorycompliance
Pharmacovigilance Requirements in Australia: Understanding RMP and cRMM
PharmaSpectrum Pty Ltd on LinkedIn