Supports the Pharmacovigilance team in reviewing, querying, documenting and reporting on all serious adverse events (SAE) & Suspected Unexpected Serious Adverse Reactions (SUSAR) cases related to clinical studies.
Provide timely and sound medical review of individual case safety reports (ICSR) from clinical trials.
Actively participates in the case initiation process (case triage) and case data inputting/data entry as more complete SAE information becomes available.
May participate in the case narrative generation, review and refinement process depending upon level of experience.
Conducts several rounds of query and response (back to site) to gain complete and accurate case information.
Navigates Safety Database including the advancing of cases within the workflow and understanding and conducting of various medical coding applications.
Represent department as medical safety lead on cross-functional study and program teams for assigned products and studies, providing expert guidance regarding safety matters and issues.
Participate in protocol development, specifically the monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans.
High Comfort Level in working in Multidisciplinary teams; providing input in team meetings and relaying information to PV management.
Participate in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports.
Contribute to preparation and review of periodic reports (DSUR, CSR)
Review and provide medical content, as needed, for key study-related documents, e.g. IB, ICF, IDMC Charter.
Participate in departmental development activities including Training Staff, SOP and Work Instructions development.
Provide guidance to staff regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective.
Participate in the regular review of safety data for assigned products for the identification of new safety signals, in accordance with signal detection practices.
Participate in Risk Management Strategy
Other activities, as needed or as requested by manager.
MD, DO or equivalent ex-US medical degree
A minimum of 3 years Drug Safety/Pharmacovigilance experience in a pre-approval setting
Oncology experience required
Experience with Oracle’ s Argus Safety Suite or comparable database required
Strong familiarity of GCP, ICH and Global regulations
Experienced in the evaluation and interpretation of data
Ability to multi-task with close attention to detail
Strong written and oral communication skills
Solid judgment and decision-making skills, including the identification and communication of relevant safety- related issues or concerns to Medical Safety Management in an appropriate and timely manner
Experienced in safety reviews of AEs/SAEs, IBs, protocols, clinical study reports, informed consents, and other safety-related documents