Safety Review Specialist

Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.

We’re looking for a Safety Review Specialist to join our Data Management team!

In this position, you will focus on ensuring the clinical integrity of the database by reviewing CRFs, data listings, and databases. You will ensure that captured data follow the rules outlined in the protocol and data management plan and according to the edit check specifications created by the lead data manager. More specifically you will perform reconciliation of adverse events, medications, physical examination and other exams, lab results, and medical history data, and review other data as defined in the edit check specification for each study.

You will be accountable for:

Reviewing CRFs, data listings, and database to ensure that captured data follow the rules outlined by the protocol and data management plan
Performing quality control on adverse events, medications, physical examination, other exams, labs, and medical history data and other data as defined in the data management plan for each study
Generating paper and electronic queries to appropriate internal or external personnel (e.g., investigational sites, Clinical Research Associates and client representatives) to resolve problematic data identified during various aspects of the safety reviews and data management process
Reviewing responses to queries for appropriateness and resolving any discrepancies
Reviewing CRFs and edit check specifications for potential data collection and representation, database structure or data entry problems, and providing feedback to the project team, when requested
Reconciling serious adverse events between the Data Management and Pharmacovigilance databases

You'll also contribute by:

Reviewing the protocol, data management plan, edit check and report specifications, in support of the data cleaning plan for projects assigned

You'll need this background to be considered:

Educated to Bachelor’s degree level or equivalent
Ideally some experience in the medical field and data management experience
Understanding and experience with up to date MS Windows Operating Systems and applications and at least one Database Management System (e.g., SAS, DataLabs, Rave, Oracle Clinical, TrialMaster, etc.)
Attentive to details and able to independently resolve a variety of issues without close supervision
Organisation & planning skills
Working knowledge of medical terminology
Excellent English communication skills (verbal, written & interpersonal)
Willing to be office based in Bratislava, Slovakia