POSITION OBJECTIVE: Responsible for supporting the Pharmacovigilance (PV) team in analyzing the safety profile of company’s investigational products, signal management and reviewing, querying, documenting and reporting on all serious adverse event (SAE) cases related to Athenex clinical studies.
Essential Job Functions/Responsibilities
- Manage team workload to ensure timely completion of case management activities & ensure reporting compliance.
- Initiate new safety projects, e.g., study safety management plans, safety charters & reconciliation plans.
- Act as liaison w/ CROs, internal depts. & external business partners on drug safety & clinical study activities.
- Ensure uniform & timely processing of safety reports in accordance with SOPs, worldwide regulatory authority & ethics expectations.
- Plan, schedule & track progress to project milestones. Facilitate project team meetings, cross functional communication and decision making.
- Partner with project leader to manage the development & execution of project team strategy. Lead Safety Physician team under guidance of VP Pharmacovigilance; develop strategy, design & implementation of pharmacovigilance programs to provide support for safety issues in clinical trials with a primary focus on protecting the safety of study subjects & ensuring compliance with clinical trial protocol, SOPs, GCP, Good Pharmacovigilance Practice & other regulatory requirements.
- Implement & manage standard PV database and associated SOPs/Working/Practices and business processes & manage overall workflow of Pharmacovigilance department.
- Assure appropriate review of all SUSAR SAE cases for regulatory reporting purposes. Act as PV/Drug safety Subject Matter Expert on cross-functional clinical studies & program teams for assigned products & provide expert guidance regarding new safety findings & trends.
- Conduct safety signal detection activities & participate in review & analysis of safety data for assigned products & participate in Risk Management Strategy.
- Assess benefit-risk information -Medical evaluation of Individual Case Safety Reports & Aggregate reports.
- Allocating assignments to each team member, reviewing performance, & providing feedback to the team in timely manner. Review & assist safety related activities associated with new drug applications/regulatory filings, benefit risk assessment & safety risk management.
- Oversee & review aggregate safety documents & safety sections of clinical trial documents on behalf of PV dept.
- MedDRA and WHODD coding and review.
- Provide safety input to study protocols, amendments, investigator brochure, clinical study reports, responses to health authority, EC/IRB queries, etc.
- Participate in PV department contributions to risk management plans, pre-filing safety activities including safety table shells, integrated safety data review, integrated safety summary document review & safety related summary devt.
- Assist VP Pharmacovigilance in developing & maintaining pharmacovigilance processes and procedures within Athenex.
- Represent department as medical safety lead on cross-functional study and program teams for assigned products and studies and provide expert guidance on safety related issues. Participate in protocol development, including monitoring and collection of safety information in clinical trial protocols, as well as statistical analysis plans.
- Provide medical review of individual case safety reports (ICSR) from clinical trials.
- Review queries created by safety physicians to be sent to the investigator
- Implement & manage industry standard PV database and associated SOPs/Working/Practices & business processes and managing the overall workflow of the Pharmacovigilance department. Participate in the analysis of safety data from clinical trials and representation in Clinical Study Reports.
- Support preparation for regulatory audits/ inspection with evaluation of current processes.
- Formulate responses to regulatory inquiries.
- Participate in department development activities including training, SOP & Work Instructions dev’t. Provide guidance to staff regarding best practices for collection, evaluation and processing of adverse experience reports.
Required Education & Qualifications
- Requires MD, DO or foreign equivalent degree and 3 years of experience with pharmacovigilance product safety in pharmaceutical, biotech or clinical research organization.
- Experience must include 3 years in medical safety assessment and preparation of aggregate reports, IB, and protocols.
- Must also have 3 years of clinical practice experience with safety assessment and action through the lifecycle of a drug product.
- Requires 3 years experience with Oracle Argus Safety Suite and with GCP, ICH, and Global regulations.
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.