POSITION OBJECTIVE: 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.
Essential Job Functions/Responsibilities
- 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.
Required Education & Qualifications
- 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
- Solid 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.
- Close attention to detail.
- Ability to collaborate well with others.
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.