Pharmacovigilance support that keeps safety data moving.
Case processing, aggregate reporting and drug safety specialists for marketed and investigational products.
Safety obligations do not pause when a team is short-staffed. Stark Associates supports pharmaceutical and biotech companies with the routine and periodic work of pharmacovigilance, and with experienced safety professionals when internal teams need extra capacity.
Case processing
Our safety associates handle intake, triage, data entry, MedDRA coding, narrative writing and quality review of individual case safety reports in the client's safety database, following the client's conventions and regulatory timelines for expedited reporting.
Aggregate reports
We support the preparation of periodic safety reports, such as periodic benefit-risk evaluation reports and development safety update reports, including data retrieval, line listings, drafting and coordination of review comments.
Literature screening and signal support
Systematic literature monitoring identifies reportable cases and relevant safety information. Our scientists can also support signal detection activities, evaluation documentation and safety review meetings, with medical judgment remaining with the client's qualified physicians.
Drug safety staffing
For organizations building or backfilling safety teams, we place drug safety associates, scientists and managers on contract or permanent terms. See talent and staffing.
How engagements work
Each engagement begins with agreed procedures, timelines and quality metrics, and a reconciliation process so that nothing falls between systems. Reporting is regular and transparent.
When clients call us
Teams usually reach out when case volumes rise after a launch or label change, when a periodic report is due while staff are stretched, when a literature backlog has built up, or when a safety database migration needs extra hands for reconciliation and testing. We size the support to the workload and step back as volumes settle, so you pay only for the capacity you need. Medical review, causality decisions and regulatory accountability always remain with your qualified people.
In the first weeks we map your conventions, train on your database and agree quality checks before taking live cases.
Drug safety services at a glance
- ICSR case management
- Adverse event reporting
- Medical review support
- Literature review
- Signal detection and analysis
- Aggregate report development
We support safety work across the product lifecycle, from compiling a clear product safety profile during development to risk management planning ahead of approval.