Drug Safety Matters

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Pharmacovigilance specialists can have very different roles depending on their organisation and job title. With so many career paths to choose from, how do you find your place? Myriam Salem from Health Canada and Francesco Salvo from the University of Bordeaux share advice on how to break into the field and navigate the job market.

Tune in to find out:

• What PV work looks like across regulators, academia and industry
• Which skills you need to remain competitive
• How to balance training and hands-on experience

Want to know more?

These are some of the leading organisations offering online courses in pharmacovigilance:

• UMC (Uppsala Monitoring Centre)
• Eu2P (European programme in pharmacovigilance and pharmacoepidemiology)
• Am2P (American program in pharmacovigilance)
• DIA (Drug Information Association)
• DSRU (Drug Safety Research Unit)

 These initiatives and events offer good networking opportunities:

• ISoP (International Society of Pharmacovigilance) student group
• ISoP annual meetings, with pre-conference training courses
• DIA annual meetings
• World Patient Safety Congress Europe
• World Patient Safety Congress Americas

 Other resources cited in the interview:

• Uppsala Reports, for pharmacovigilance news stories
• Two-part podcast on artificial intelligence in pharmacovigilance

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Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.

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Global pharmacovigilance requires harmonised methods, but solutions must be tailored to the local context. We sat down with Salvador Alvarado and Matthew Barwick from Uppsala Monitoring Centre to explore how local constraints affect drug safety and how a new film series by UMC can inspire PV professionals across borders.

Tune in to find out:

• How the thalidomide tragedy triggered a global pharmacovigilance collaboration
• How UMC supports members of the WHO Programme for International Drug Monitoring
• How to communicate science effectively on camera

Want to know more?

Watch The WHO PIDM in Focus film series on YouTube.

Read about the benefits of the WHO PIDM, its members and UMC’s role in the programme.

Revisit these related episodes from the Drug Safety Matters archive:

• Unpacking the WHO Global Smart Pharmacovigilance Strategy
• Communicating science through film

Please note that the views and opinions expressed in the episode are not those of Uppsala Monitoring Centre.

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Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.

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From signal assessor to researcher, QPPV and more, pharmacovigilance specialists play vital roles that differ widely based on their organisation and job title. But where should you begin if you're just starting your career or trying to break into the field?

For our next episode, we will be chatting to Myriam Salem, national compliance and enforcement supervisor at Health Canada, and Francesco Salvo, professor and pharmacologist at Université de Bordeaux, about careers in pharmacovigilance, including:

• What types of jobs are out there
• How to get started
• What skills you need to remain competitive

So here’s your chance to ask us anything! Text us your questions for Myriam and Francesco by Tuesday 30 June for a chance to feature on the show.

We look forward to hearing from you!

Got a story to share?
We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!

About UMC
Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.

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Pharmacovigilance has traditionally focused on the patient at the receiving end of a medicine. But what happens to medicines once they leave the body? In this episode, Valentina Giunchi and Joe Mitchell unpack the emerging field of ecopharmacovigilance and explore how the One Health approach is reshaping the way we think about medicine safety across human, animal, and environmental systems. 

Tune in to find out:

• Where in the environment pharmaceutical residues are turning up, and why this should be on every pharmacovigilance scientist's radar
• How the dramatic collapse of India's vulture populations in the early 2000s speaks to the importance of the One Health approach 
• Practical solutions, from smarter prescribing and greener pharmaceuticals to take-back schemes for unused medicines, that can help curb pharmaceutical pollution.

Want to know more?

For a deep dive into ecopharmacovigilance, the following references provide foundational information on the topic in pharmacovigilance, most of them penned by Professor Giampaolo Velo, who coined the term:

• The revised Erice declaration for the inclusion of environmental issues in pharmacovigilance
• A book chapter on ecopharmacovigilance in the 2017 SpringerLink book “Pharmacovigilance”, featuring our very own Ralph Edwards and Marie Lindquist as editors
• A paper summarising the main concepts in ecopharmacovigilance and pharmaceutical pollution

A paper with Valentina Giunchi as a co-author on environmental sustainability as an essential component of rational medicine use.

A recent paper with Joe Mitchell as a co-author, using the One Health approach to investigate pharmacovigilance database reports on antimicrobial resistance. 

Got a story to share?
We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!

About UMC
Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.

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For all its ease and speed, disproportionality analysis can be distorted by many biases, making it easy to misuse and misinterpret. Michele Fusaroli from Uppsala Monitoring Centre and Eugene van Puijenbroek from the Netherlands pharmacovigilance centre Lareb explain why we shouldn’t abuse this powerful but fragile tool.

Tune in to find out:

• Why we should never treat disproportionality signals as verdicts
• How poorly performed analyses affect scientists, regulators and patients
• How to avoid the most common sources of bias 

Want to know more?

• Michele and Eugene’s paper in Drug Safety is a concrete guide to charting and sidestepping the pitfalls of disproportionality analysis.
• In another Drug Safety paper, Michele and colleagues show how directed acyclic graphs (DAGs) can help map and address biases in disproportionality analysis.
• Michele also reviewed the method’s limitations in Uppsala Reports, where he argues that ‘pharmacovigilance must move past crude disproportionality’.
• Last year, Retraction Watch covered the spike in pharmacovigilance studies in the literature and why some journals decided to ban drug safety database papers.
• Previously on Drug Safety Matters, Michele and Daniele Sartori discussed the READUS-PV guidelines for reporting disproportionality analyses.
• In 2016, the IMI PROTECT project published recommendations to improve signal detection practices, especially for quantitative methods like disproportionality analysis.
• UMC’s guidebook on signal detection in small datasets offers step-by-step advice for qualitative methods and manual case review.

Got a story to share?
We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!

About UMC
Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.

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Medical device pharmacovigilance is complicated. Alongside clinical safety, there are technology risks, from cybersecurity threats to outdated software, that can put patients at risk. 

In this two-part episode, Omar Aimer, President of ISoP and former co-lead of the Medical Device Safety Special Interest Group, discusses the challenges with medical device safety monitoring and what needs to change to keep patients safe.

Tune in to find out:

• How reporting for medical devices differs from medicines and vaccines
• How AI may be used for predictive safety monitoring
• Why regulatory and data harmonisation remains the key to improving medical device safety

Want to know more?

Listen to the first part of the interview here.

If you would like to learn more about the status and suggestions for future improvements in medical device safety monitoring, Omar has recently published a paper on the topic in the journal Drug Safety, as well as an article for Uppsala Reports.

Much like any other market, AI/ML are fast infiltrating the medical device field, and may require tailored frameworks for effective safety monitoring, as discussed by Babic et al. in their Nature paper.

Founded in 2018, ISoP’s Medical Device Safety Special Interest Group works to develop “best practices and policy in the field of medical device performance monitoring and safety surveillance”.

Got a story to share?
We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!

About UMC
Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.

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Disproportionality analysis is the go-to method for signal detection in pharmacovigilance, but it is also easy to misuse and misinterpret.

For our next episode, we will be chatting to pharmacovigilance scientists Michele Fusaroli from Uppsala Monitoring Centre and Eugene van Puijenbroek from the Netherlands Pharmacovigilance Centre Lareb about the method’s pitfalls, including:

• how to recognise common sources of error
• how to mitigate bias
• best practices for careful design and interpretation of disproportionality analyses

So here’s your chance to ask us anything! Text us your questions for Michele and Eugene by Wednesday 4 March for a chance to feature on the show.

We look forward to hearing from you!

Got a story to share?
We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!

About UMC
Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.

Send us a voicemail!

Medical device pharmacovigilance is complicated. Alongside clinical safety, there are technology risks, from cybersecurity threats to outdated software, that can leave patients vulnerable.  

In this two-part episode, Omar Aimer, president of ISoP and former co-lead of the Medical Device Safety Special Interest Group, discusses the challenges with medical device safety monitoring and what needs to change to keep patients safe. 

Tune in to find out:

• What defines a medical device and how prevalent they are in our society
• Why device safety monitoring is different from medicines and vaccines, and where current surveillance still falls short
• How global initiatives aim to strengthen safety monitoring standards

Want to know more?

Listen to the second part of the interview here. 

If you would like to learn more on the status and suggestions for future improvements in medical device safety monitoring, Omar has recently published a paper on the topic in the journal Drug Safety, as well as an article for Uppsala Reports.

Much like any other market, AI/ML are fast infiltrating the medical device field, and may require tailored frameworks for effective safety monitoring, as discussed by Babic et al. in their Nature paper.

Founded in 2018, ISoP’s Medical Device Safety Special Interest Group works to develop “best practices and policy in the field of medical device performance monitoring and safety surveillance”.

Got a story to share?
We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!

About UMC
Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.

Send us a voicemail!

This special episode was recorded just before the 43rd Annual Meeting of the WHO Programme for International Drug Monitoring wrapped up in Cairo, Egypt. Held from 27 to 29 October 2025, the meeting brought together representatives from more than 80 member states, along with senior experts and regulatory leaders from WHO headquarters and regional offices. Discussions focused on strengthening pharmacovigilance for women of childbearing age and children, in light of WHO’s newly finalised Global Smart Pharmacovigilance Strategy. 

In this episode, you’ll hear an abridged interview with Shanthi Pal, WHO Pharmacovigilance Team Lead, as she unpacks the new strategy and what it means for countries.

Want to know more?

• Read WHO’s “Global smart pharmacovigilance strategy” (Geneva: World Health Organization; 2025). 
• Explore WHO’s work on pharmacovigilance through the Programme for International Drug Monitoring (PIDM) and the WHO Pharmacovigilance Team.
• Learn more about regulatory systems strengthening and the WHO Global Benchmarking Tool (GBT) for medicines and vaccines.
• Discover the WHO network for regulatory systems strengthening – the Coalition of Interested Parties (CIP), of which UMC is a member.
• Visit the UMC website to find out more about the WHO PIDM and UMC’s role in it.

Got a story to share?
We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!

About UMC
Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.

Send us a voicemail!

Far from a future add-on, artificial intelligence is already embedded in the cycle of drug safety, from case processing to signal detection. Versatile generative AI models have raised the bar of possibilities but also increased the stakes. How do we use them without losing trust and where do we set the limits?

In this two-part episode, Niklas Norén, head of Research at Uppsala Monitoring Centre, unpacks how artificial intelligence can add value to pharmacovigilance and where it should – or shouldn’t – go next.

Tune in to find out:

• How to keep up with rapid developments in AI technology
• Why model and performance transparency both matter
• How to protect sensitive patient data when using AI

Want to know more?

Listen to the first part of the interview here.

The CIOMS Working Group XIV published its recommendations for the use of AI in pharmacovigilance in December 2025. For a summary of the report's guiding principles and examples of how they can be applied, check out this article in Drug Safety.

Earlier this year, the World Health Organization issued guidance on large multi-modal models – a type of generative AI – when used in healthcare.

Niklas has spoken extensively on the potential and risks of AI in pharmacovigilance, including in this presentation at the University of Verona and in this Uppsala Reports article.

Other recent UMC publications cited in the interview or relevant to the topic include:

• a pre-print on the revised vigiMatch algorithm for duplicate detection
• an article on the pitfalls of disproportionality analysis
• a pre-print on critically appraising AI applications for rare-event recognition

For more on the ‘black box’ issue and maintaining trust in AI, revisit this interview with GSK’s Michael Glaser from the Drug Safety Matters archive.

Got a story to share?
We’re always looking for new topics and interesting voices. If you have an idea or any other feedback for the show, get in touch!

About UMC
Uppsala Monitoring Centre promotes safer use of medicines and vaccines for everyone everywhere. Follow us on Facebook, LinkedIn, X, and Bluesky.