MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies. Our team of 350+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer. Our products and platforms have attracted multiple partnerships with leading pharmaceutical and biotechnology companies around the globe.

MacroGenics is a bold, highly engaged, and diverse team driven by a passion for improving the lives of patients through innovative science. We are committed to an inclusive workplace built on trust and respect. We value and nurture strong connections with one another and foster collaborative relationships. We empower our people and drive personal accountability. We encourage curiosity and embrace our entrepreneurial spirit. We celebrate our successes and create a learning environment where all employees can thrive!

Summary of Position

The Sr. Product Safety Manager/Associate Product Safety Director is responsible for supporting and managing day-to-day pharmacovigilance operational activities to ensure patient safety and regulatory compliance across global pre/post-marketing programs.He/she will serve as a pharmacovigilance/drug safety operational subject matter expert and will develop and/or contribute to department standard operating procedures, guidelines, methods and techniques to aid in pharmacovigilance/drug safety activities, maintain oversight of safety vendors, ensure timely submission of safety information to regulators, ethics committees, and investigators, contribute to and maintain pharmacovigilance agreements and safety management plans, mentor staff, and perform other operational tasks that assist the department with meeting MacroGenics objectives.

Responsibilities and Job Duties

• Remains current with domestic and global safety reporting requirements and makes recommendations for required changes to department processes and systems to ensure compliance. Facilitates execution of any agreed upon changes.
• Participates in the review and approval of new safety vendors. Reviews and contributes to statements of work, establishment of contracts, and budgets.
• Participates in the selection, validation, implementation, and training of safety software and other applications used to support product safety activities, as needed
• Assist in vendor oversight and management , as appropriate, to ensure that safety-related project milestones are met within required timelines.
• Represents Product Safety at product team meetings as appropriate to respond to questions and/or addresses concerns. Raises more complex issues with manager and discusses and recommends resolutions.
• Contributes to timely and accurate communications with other parts of the organization such as regulatory affairs, clinical operations, and data management regarding product safety operational activities .
• Drafts, reviews and finalizes pharmacovigilance agreements (PVAs) with MacroGenics business partners and ensures compliance with PVAs.
• Participates in internal audits and regulatory authority pharmacovigilance quality assurance inspections.
• Creates, contributes to and maintains standard operating procedures, work practice documents, resource documents and safety management plans for pharmacovigilance/drug safety processes. Ensures that staff is educated and knowledgeable as appropriate.
• Identifies and documents deviations from established processes and implements corrective and preventive actions to maintain compliance with global regulations.
• Maintains and evaluates Product Safety metrics, including execution of metric reports, creating summaries of metrics, identifying any possible issues, creating an action plan, and providing reports to product safety management.
• Oversees and contributes to the development of safety data collection forms, tracking reports, communication flows, templates, job aids, and training material. Manages the implementation of new documents and monitors adherence. Improves as necessary.
• Provides Subject Matter Expertise pertaining to individual case safety report (ICSR) processing activities.
• Ensures safety files and documentation are compatible with the departmental and corporate document management system and ensures regulatory compliance.
• Provides quality review of documents including ICSR and aggregate reports, as necessary. Communicates issues and ensures resolution.
• Manages the safety database workflow to ensure timely completion and reporting of ICSRs.
• Assist product safety staff in safety/clinical database reconciliation activities.
• Collaborates with Product Safety Systems staff, pertaining to safety database enhancements. Makes recommendations based on user needs. Assists in the preparation of aggregate safety reports (e.g DSURs, 6-monthly line listing) including execution of line listings from the safety database and authoring of the document.
• Coordinates and directs trainings and professional development of Product Safety Team members including training and mentoring of newly-hired team members.
• Performs other related responsibilities and duties as required by business need and/or assigned by Product Safety Management.

Minimum Qualifications

Education and Certifications

• Bachelor of Science in Nursing, Pharmacy or equivalent degree

Experience

Sr. Product Safety Manager

• Seven (7) years of relevant experience in drug safety/pharmacovigilance

OR

• At least three (3) years of clinical experience in a patient care setting and four (4) years of drug safety/pharmacovigilance in pharmaceutical industry

Associate Product Safety Director

• Eight (8) years of relevant experience in drug safety/pharmacovigilance

OR

• At least three (3) years of clinical experience in a patient care setting and five (5) years of drug safety/pharmacovigilance in pharmaceutical industry

Knowledge, Skills and Abilities

• Knowledge of global clinical trial and post-marketing pharmacovigilance methodologies
• 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 Agreements, Regulatory Approval Process, Drug Development and GXP (Good Pharmacovigilance Practice).
• Knowledge of applicable domestic and global safety reporting requirements, ICH/GCP guidelines
• 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 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.
• Intermediate to advanced-level computer skills including word processing and safety database management.

Supervisory Responsibilities
No

Preferred Qualifications
Vendor management experience
Knowledge of safety databases