20 Commerce Drive, Suite 100 , NJ
Job Category: Clinical: Pharmacovigilance (PV)/Drug Safety
Job Number: 2049
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
- Ability to collaborate well with others