Senior Drug Safety Associate

Overview

The Senior Drug Safety Associate candidate works in a team-oriented, dynamic, and collaborative environment. This person would manage the drug safety mailbox, track case workflow, support the drug safety activities including case management while adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures

Essential Functions and Responsibilities

• Supports all clinical safety (CS) and pharmacovigilance (PV) aspects of Iovance clinical studies and commercial products
• Monitors and manages safety inbox including archiving of emails and documents
• Updates and manages various workflow and submission trackers
• Reviews triage emails and provides triage assessments
• Performs case management including receipt, duplicate check, book-in, assessment of seriousness and expectedness, data entry and narrative writing
• Reviews key fields of cases, including narratives, to ensure case accuracy
• Ensures medical coding for all incoming cases is accurate based on MedDRA (Medical Dictionary for Regulatory Activities) and WHO Drug Dictionary coding standards
• Reviews supporting documentation accompanying individual case safety reports and identify pertinent information for incorporation into the case narrative
• Correctly identifies cases requiring targeted follow-up, determine and send relevant follow-up queries
• Consults with safety physicians, medical monitors, clinical operations, or other relevant affiliates as needed on safety data issues (i.e., obtaining clarification on SAE reports including missing key information such as causality, seriousness or reported term)
• Demonstrates general understanding of how to assess labeledness/expectedness for study products and commercial products
• May assist manager with other projects including, but not limited to, the preparation of training materials to support the case processing workflow, global PV system compliance, and vendor management activities
• May support PV Audit and Inspection preparation
• Works independently and prioritizes workload to ensure all relevant internal and external timelines are met
• May participate as a member of Study Management Teams (SMTs)
• Performs clinical trial reconciliation with minimal supervision
• May perform electronic reporting (E2B) of individual case safety reports, and submission of aggregate reports ensuring timely submission and collecting acknowledgments of receipt from Regulatory Authorities and Business Partners as applicable
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.

• Perform miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

• Health care professional degree (e.g., RN, PharmD) and 2+ years of drug safety experience or 1+ year of clinical practice experience. Or a BS degree in a life sciences field and 3+ years of drug safety experience. Or 4+ years of experience in the drug safety field
• 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, Power point and Word).
• Safety database and case management experience
• Ability to assess data and understand the medical/safety implications
• Demonstrates initiative, teamwork and accountability
• Demonstrated success working both independently and in collaboration with others
• A quality driven individual with strong attention to detail and accuracy is required
• Strong organizational skills, and ability to adapt to change
• Ability to follow guidelines and procedural documents
• Self-motivated and capable of working independently

Preferred Education, Skills, and Knowledge

• Oncology experience or knowledge preferred
• Understanding of safety database structures and familiarity with data retrieval tools are preferred

The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodations may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request an accommodation.

Physical Demands and Activities Required (This would need to be adjusted by HRBP depending on the position and needs using the assessment form)

• Must be able to remain in a stationary position standing or sitting for prolonged periods of time.
• Must be able to move about inside an office and exert up to 10 pounds of force occasionally or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects.
• Must have visual acuity to perform activities such as: preparing and analyzing data and figures, viewing a computer screen, and extensive reading.
• 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.

Mental: Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadlines

Work Environment

This job operates in a professional or remote office environment and requires operating standard office equipment and keyboards. 

The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.

Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.

By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice. 

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