Drug Safety Associate at Iovance Biotherapeutics, Inc. Apply Now!
Looking to start a career in drug safety? The Drug Safety Associate I role offers a dynamic and collaborative environment where professionals ensure compliance with pharmacovigilance regulations. From managing adverse event reports to working with regulatory agencies, this position plays a crucial role in ensuring patient safety. Learn more about the essential responsibilities, qualifications, and skills needed to excel in this role.
Essential Functions and Responsibilities
- Monitor and manage safety inboxes including archiving emails and documents
- Monitor the incoming reports and perform initial and follow-up triage to identify adverse events and/or quality issues
- Perform duplicate check, book-in, and initial data entry of all incoming reports
- Review follow-up information for cases and make initial determination of significant information
- Liaise with safety physicians and Drug Safety managers as needed on safety data issues
- Recognize situations that require assistance from more senior staff members or Safety Physicians and seek assistance from appropriate internal resources
- Demonstrates general understanding of appropriate labeling documents for study products
- Able to manage workload, ensuring departmental workflow processes are followed according to the outlined timelines
- May assist managers with ad hoc projects or participate in other activities, as needed or as requested by the supervisor
- May participate in inspection readiness activities such as preparation and organization of safety documents
- Remain current with Iovance SOPs, guidance documents and database technology
- Able to work independently and prioritize workload with minimal supervision
- Perform miscellaneous duties as assigned
Required Education, Skills, and Knowledge
- Healthcare professional degree (i.e., RN, PharmD) with minimum of 1 year professional experience or Bachelor’s degree in life sciences or equivalent relevant scientific qualifications with minimum of 2 years of experience in drug safety or equivalent industry experience
- Knowledge of global safety regulations, ICH Guidelines, and other applicable regulatory guidance documents
- Excellent interpersonal and communication skills, both written and oral
- Excellent computer skills in Microsoft environment (Microsoft Excel, PowerPoint, and Word)
- Safety database experience preferred
- Ability to assess data and understand the medical/safety implications
- Demonstrates initiative, teamwork and accountability
- Strong organizational skills, and ability to adapt to change
- Ability to follow guidelines and procedural documents
Physical Demands and Activities Required
Must be able to remain in a stationary position standing or sitting for prolonged periods of time. Must have visual acuity to perform activities such as preparing and analyzing data and figures. This position requires repetitive motion, substantial movements (motions) of the wrist, hands, and/or fingers. Must be able to communicate with others to exchange information.
Keywords: Drug Safety Associate, Healthcare, Safety Regulations, Pharmacovigilance, Remote Work.
