Returning Candidate?

Product Safety Medical Director

Product Safety Medical Director

ID 
2018-1220
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

The Product Safety Medical Director performs safety surveillance activities and provides scientific/clinical/pharmacovigilance expertise for safety data analysis from various sources including pre-clinical studies, clinical studies, literature and other information sources. This position will focus on the proactive identification, evaluation, and risk management of safety risks to patients for assigned MacroGenics’ products throughout the product’s life cycle.

 

Responsibilities and Job Duties

  • Perform medical review of safety events to ensure accuracy and completeness of safety information and consistency in medical coding; provide the company case assessment, and generate the analysis of similar events
  • Responsible for proactive pharmacovigilance signal detection activities for designated MacroGenics products, including signal identification, evaluation, interpretation of safety signals and trends and communication (written and verbal) of safety risks and documentation of all signal review activities
  • Collaborate with other applicable functional areas, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities, as needed, to evaluate and manage safety signals for MG products; provide support to cross-functional ad-hoc teams set up to address urgent and important safety issues
  • Prepare and author aggregate safety reports such as DSURs, semi-annual Suspected Unexpected Serious Adverse Reactions (SUSARs) reports, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and EU Risk Management Plans in coordination with the Executive Director, Product Safety according to the agreed process and timelines
  • Contribute to the safety sections of clinical documents, including review and approval of the safety portion of protocols, statistical analysis plans, annual reports, clinical study reports, Investigator brochures, and other documents
  • Runs the Safety Risk Management Committee including setting agendas, producing necessary data outputs, facilitating discussions, and documenting conclusions
  • Participate in the preparation and maintenance of Reference Safety Information (RSI) and product labeling (e.g., Developmental Core Safety Information [DCSI], Company Core Safety Information [CCSI], Investigator Brochure [IB], etc.)
  • Author responses for regulatory or other ad-hoc safety queries which includes proposing response strategies and reviewing of relevant data
  • Contribute to the preparation and review of safety risk section(s) of Investigator brochures (IBs), protocols, informed consent/assent forms, clinical study reports/synopses, Integrated Summary of Safety)/Common Technical Document (CTD) submissions and other documents as needed; ensure risk-reduction strategies are implemented timely and appropriately in relevant documents
  • Maintain knowledge of disease states for therapeutic area(s) for assigned products
  • Demonstrate knowledge and ensure compliance with current and applicable global PV regulations/guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.) and with corporate and departmental policies and procedures
  • Other duties as assigned by manager

Qualifications

Education & Other Credentials

  • M.D.

 

Experience

  • At least three years of experience working in Product Safety within a biotech/pharmaceutical company or CRO
  • Prior experience working as a physician in a clinical setting
  • Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data and developing risk management/mitigation strategies
  • Experience in the preparation and authoring of aggregate safety reports, RMPs, and RSI

 

Knowledge, Skills and Abilities

  • Ability to apply principles, concepts and industry best practices governing pharmacovigilance and risk management in assigned projects.
  • Excellent verbal and written communication skills, as well as presentation and team-interaction skills are necessary
  • Proficiency in Microsoft Office
  • Strong organizational skills, including the ability to prioritize independently with minimal supervision

 

Supervisory Responsibilities

No

 

Preferred Qualifications

  • Experience with Argus Safety Database
  • Experience with signal detection software (e.g. JReview, Spotfire)
  • Previous experience in oncology therapeutic area, especially with immunotherapeutics

 

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.