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 supporting ongoing pharmacovigilance activities pertaining to MacroGenics’ products. The incumbent in this role will serve as a safety database and pharmacovigilance subject matter expert; develop and/or contribute to department standard operating procedures, guidelines, methods and techniques to aid in pharmacovigilance/drug safety activities; and perform other tasks, including but not limited to vendor oversight, adverse event case management, generation of listings/reports, coordination and collaboration with other functional areas, etc. as assigned to ensure regulatory compliance while meeting MacroGenics objectives.
Responsibilities and Job Duties
- Ensure complete and accurate case compilation by acquisition of all relevant event information, data entry and maintenance of cases in safety database, development of safety data collection forms and tracking reports, reconciliations of serious adverse events between the safety and clinical study databases, and summarization of serious cases for regulatory authorities and business partners
- Coordinate 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
- Participate in the development of product Benefit-Risk Assessments and Risk Management Plans (RMPs) and Risk-Evaluation and Mitigation Strategies (REMS)
- Function as a Product Safety representative at cross-functional product team meetings as appropriate
- Provide subject matter expertise pertaining to the Safety Database including but not limited to data entry, queries, case reporting, and report generation
- Serve as a Product Safety functional area resource pertaining to pharmacovigilance activities by maintaining up to date knowledge of evolving domestic and international regulations, guidances, and industry best practices pertaining to pharmacovigilance and drug safety
- Apply pharmacovigilance systems and regulatory knowledge to proactively manage and propose solutions to arising complex issues and problems by gathering, evaluating, and analyzing data
- Manage CROs or contractor safety staff, as appropriate, to ensure that safety-related project milestones are met within required timeline.
- Contribute to and develop standard operating procedures, guidelines, methods and techniques to aid in core safety surveillance processes and ensure regulatory compliance
- Maintenance of safety files and documentation that are compatible with the departmental and corporate document management system and ensure regulatory compliance
- Review product and class safety information including pre-clinical, clinical and post-marketing data from internal and external sources
- Contribute to timely and accurate communications with other parts of the organization and business partners, as appropriate regarding expedited safety reports, product safety risk management, and compliance
- Assist in preparation of aggregate reports (e.g DSUR) including execution of line listings from the safety database and assist with authoring and review of the document
- Provide quality review of documents, as necessary
- Other related responsibilities and duties, as required by business need and/or assigned by Product Safety Management
Education & Other Credentials
Bachelor of Science in Nursing, Pharmacy, Life Science or equivalent degree
- 1 year of clinical experience in a patient care setting
- At least 5 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
- Knowledge of 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).
- Advanced knowledge of applicable domestic and international safety reporting requirements, ICH/GCP guidelines, MedDRA and WHO DRUG dictionaries
- Excellent oral and written communication skills – ability to effectively represent Product Safety in various internal and external meetings
- Ability to make effective decisions and manage several high-priority, fast-paced activities within required timelines
- Ability to create a quality work in a timely fashion
- Ability to manage people and processes to meet corporate objectives
- Ability to work independently with minimal supervision, but seek appropriate involvement from senior management regarding complex issues beyond position scope
- Ability to work as part of a team in a matrix environment
- Ability to be flexible and adapt to change
- Solid knowledge of applicable domestic and international safety reporting requirements
- Intermediate to advanced-level computer skills including word processing and safety database management
Experience with Argus Safety Database