Drug Safety Associate I

Overview

The Drug Safety Associate I 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 while adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures. Ensures compliance with standard operating procedures, regulatory, safety and pharmacovigilance in compliance with national and international regulations, such as the Food and Drug Administration (FDA), World Health Organization, country, and regional regulations for the reporting of adverse events to regulatory agencies.

Essential Functions and Responsibilities

The primary responsibilities of the DSA I include collection, initial assessment, electronic filing, and data entry of serious adverse event (SAE) data, both clinical & post-marketed, into Iovance global safety database and other relevant department folders. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise.

• 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
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Required Education, Skills, and Knowledge

• Healthcare professional degree (i.e., RN, PharmD) with minimum of 1year professional experience or Bachelors’ 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, Power point and Word).
• Safety database experience preferred
• 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 

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

• 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 workplace or remote office environment and requires standard office equipment and keyboards. Employees who work remotely are expected to maintain their workspace and environment safely and free from safety hazards.

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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