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Product Safety Specialist I/II

Product Safety Specialist I/II

ID 
2018-1223
Category 
Clinical Development
Job Location 
US-MD-Rockville
Type 
Regular Full-Time

More information about this job

Overview

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases.  Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.

 

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Summary of Position

This is an individual contributor position responsible for the management of clinical trial adverse event reports. The incumbent in this role will receive, process, and follow-up on adverse event reports to support pharmacovigilance activities and ensure regulatory compliance. Tasks include but are not limited to: data entry; coding; assessment; narrative writing; generating queries; reconciliation with clinical databases, business partners and other vendors; and assisting in the preparation of aggregate reports.

Responsibilities and Job Duties

  • Receive and process adverse event reports from clinical trials and marketed products including data entry, coding, assessment, narrative writing, and collection of follow-up information to ensure complete case compilation. Maintain safety files and documentation that is compatible with the department and corporate document management system and ensure regulatory compliance.
  • Assist in the development of safety data collection forms and tracking reports.
  • Reconcile serious adverse events between the safety and clinical study databases. Document SAE reconciliation results/discrepancies and issue queries to resolve the discrepancies.
  • Generate Investigator Notification Letters
  • Comply with Business Partner Pharmacovigilance and Safety Data Exchange Agreements. Perform routine reconciliation with Business Partners and vendors.
  • Remain current with proposed changes to domestic and international safety reporting requirements and make required changes to processes and systems to ensure compliance.
  • Contribute to development of standard operating procedures for core safety surveillance processes.
  • Review of product and class safety information including pre-clinical and clinical data from internal and external sources.
  • Function as a Product Safety representative at product team meetings as appropriate and contribute to timely and accurate communications with other parts of the organization regarding expedited safety reports, product safety risk management, and compliance.
  • Assist in the preparation of aggregate reports (e.g DSUR, PBER) including execution of line listings from the safety database and providing quality review of documents as necessary.
  • Maintain safety files and documentation that are compatible with the department and corporate document management system and ensure regulatory compliance.
  • Other related responsibilities and duties, as required by business need and/or assigned by manager

Additional Duties for Product Safety Specialist II

  • Manage CRO or contractor safety staff, as appropriate, to ensure that safety-related project milestones are met within required timelines
  • Ensure complete case compilation by acquisition of all relevant event information, data entry and maintenance of cases in safety database
  • Develop safety data collection forms and tracking reports
  • Coordinate the preparation of data for safety review committees including, relevant cumulative listings/tables, product profile and case summaries, and analyses based upon safety review committee recommendations
  • Assist in the development of product Benefit-Risk Assessments and Risk Management Plans (RMPs) and Risk-Evaluation and Mitigation Strategies (REMS)
  • Maintain and evaluate Product Safety metrics and quality plan, including execution of metric reports, creating summaries of metrics, identifying any possible issues, and create an action plan
  • Assist in maintaining Pharmacovigilance System Master File (PSMF)
  • Providing quality review of documents, as necessary

Qualifications

Education, Credentials & Experience

Product Safety Specialist I

  • Bachelor of Science, preference for a nursing, pharmacy or scientific degree
  • 2 years of clinical experience in a patient care setting or 1 year of pharmacovigilance/drug safety experience in industry or equivalent experience

Product Safety Specialist II

  • Bachelor of Science, preference for a nursing, pharmacy or scientific degree
  • 2 years of clinical experience in a patient care setting or 2 years of pharmacovigilance/drug safety experience in industry or equivalent experience
  • Experience with medical writing and summarization of clinical safety information

Knowledge, Skills and Abilities

  • Familiarity with applicable domestic and international safety reporting requirements, ICH/GCP guidelines, MedDRA and WHO DRUG dictionaries.
  • Excellent oral and written communication skills
  • Ability to manage several high-priority, fast-paced activities within required timelines
  • Ability to create quality work in a timely fashion
  • Ability to work independently with minimal supervision, but seek appropriate involvement from senior management regarding complex issues beyond position scope.
  • Intermediate to advanced-level computer skills including word processing and safety database management.

Additional Requirements for Product Safety Specialist II

  • Familiarity with safety databases, data entry platforms, adverse event data collection processes, case processing, submission of safety reports to health authorities, Safety Management Plans, Pharmacovigilance Safety Data Exchange Agreements, Regulatory Approval Process, Drug Development, and GXP (Good Pharmacovigilance Practice).
  • Working knowledge of applicable domestic and international safety reporting requirements, ICH/GCP guidelines, MedDRA and WHO DRUG dictionaries

Supervisory Responsibilities

 No

Preferred Qualifications

Experience with Argus Safety Database

 

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

 

For more information about our commitment to equal employment opportunity, please click here.