Medical writing in pharmacovigilance is not just writing. It is the point where safety data, process outputs, cross-functional input, and benefit-risk judgement come together into a document regulators can evaluate.

In Episode 4 of What's Next in PV, Tereza Korecka speaks with Katarina Cechlovska and Hana Sourkova from NextPV Services about what strong PV medical writing actually requires, including:

• What medical writing covers in pharmacovigilance, from case narratives to aggregate reports and risk management documents
• Why aggregate reports depend on signal detection, risk minimisation, case collection, exposure data, regulatory input, and source-data quality
• Where DSURs, RMPs, PSURs/PBRERs, and addenda to clinical overviews appear across the product lifecycle
• Why teams underestimate timelines, review cycles, and cross-functional coordination
• Common quality issues such as inconsistent data, outdated content, and late submissions
• What works, and what breaks, when medical writing is outsourced
• How a small biotech should start planning its first major PV document

This is a practical conversation for PV teams, regulatory teams, and biotech leaders who want documents that are not only submission-ready, but defensible.

Hosted by Tereza Korecka | Guests: Katarina Cechlovska and Hana Sourkova, NextPV Services

(00:12) - Recorded intro and episode overview(00:53) - Opening and guest introductions(00:58) - Defining medical writing in pharmacovigilance(01:10) - Safety documents across the product lifecycle(01:59) - Fixed structures, regulatory expectations, and strict timelines(02:40) - Why medical writing is more than "just writing"(02:56) - Aggregate reports, data interpretation, and the benefit-risk story(04:52) - Weak writing as a symptom of weak upstream process(05:44) - When these documents appear across the product lifecycle(06:00) - DSURs, RMPs, PSURs/PBRERs, and ACOs(07:12) - Documents as the evolving picture of benefit-risk over time(07:34) - Why teams underestimate the effort and timelines(07:58) - Medical writing timelines, review cycles, and data readiness(09:32) - Last-minute data chasing, review chaos, and lower document quality(10:59) - "Garbage in, garbage out" applied to medical writing(11:17) - Inputs and contributors needed for aggregate reports(13:01) - Authorship, reviewers, contributors, and deadlines(13:43) - Quality and compliance failure question(13:56) - Common quality failures: inconsistent data, outdated content, late submission(14:57) - Process failures behind aggregate report issues(16:06) - Outsourcing medical writing when internal capacity is limited(16:31) - Outsourcing while retaining MAH accountability(18:49) - Why outsourcing works best as a connected partnership(19:52) - Small biotech scenario: preparing a first major PV document(20:24) - Start with planning, document calendar, owner, and source-data checklist(21:12) - Reusing existing materials and identifying high-risk gaps(23:05) - Final advice question: reducing submission stress and findings(23:29) - Final advice: start long before the deadline(24:29) - Good documents reflect data quality and clear ownership(24:53) - Closing remarks

Keywords:pharmacovigilance, medical writing, PV medical writing, DSUR, PSUR, PBRER, RMP, benefit-risk evaluation, aggregate reports, drug safety, regulatory documents, biotech PV, submission readiness