Biomea Fusion is hiring an Associate Director, Drug Safety and Pharmacovigilance to join our growing Drug Safety team. The successful candidate contributes to the routine drug safety activities. In addition, this individual will contribute to filing activities that are part of new drug applications, which can include activities such as preparing/editing regulatory documents and participating in responses to questions from Regulatory Agencies. Industry experience is preferred. The position will report to the Executive Director Drug Safety and Pharmacovigilance.
- This individual has accountability for the assigned PV activities in Biomea Fusion
- Assists Head of Drug Safety for drug safety and pharmacovigilance in activities for ensuring corporate compliance with all applicable laws and regulations and as appropriate, local, and foreign regulatory reporting requirements and for signal detection, evaluation, and risk management
- Supports Pharmacovigilance Department direction, standards, and processes for supporting corporate safety monitoring activities
- Assists Head of Drug Safety for drug safety and pharmacovigilance in activities for monitoring patient safety, e.g., adverse event reports for potential safety related issues and provides recommendations when potential issues are identified
- Supports to ensures that all safety reports received from any source are reviewed according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures
- Performs Quality Control reviews of assigned cases to ensure the accuracy, integrity, medical reviews, and completeness of information entered in the safety database as needed
- Liaises with Medical Monitors in Clinical Development to ensure that appropriate medical review and assessment is provided for adverse event reports received and non-clinical safety findings reported
- Liaises with Medical Monitors in the analysis, identification and reporting or possible trends and concerns regarding Biomea Fusion products, and key competitive products, including the identification and evaluation of safety signals through the assessment of single case reports, aggregate safety reports and review of relevant literature for safety information pertinent to product safety
- Assists in the development of safety surveillance and risk management plans for drug development programs
- Supports the preparation of expedited and aggregate safety reports (e.g., 15-day Alert Report, SUSAR, PSUR, US PADER, Annual Safety Report, DSUR, IND Annual Report, etc.)
- Assists in the preparation and revision of company product labeling as appropriate
- Assists in the preparation and review of safety section(s) of investigator brochures, protocols, informed consent forms, statistical analysis plans, clinical study reports, NDA/BLA/CTD submissions and other
- Collaborates with, and provides pharmacovigilance guidance and support for interdepartmental and/or corporate initiatives
- Ensures awareness and training of appropriate Company personnel and external groups of PV and Drug Safety principles, policies, and SOPs
- Monitors industry best practices, changes in global safety regulations and guidelines for marketed and investigational projects and recommends changes and upgrades to existing departmental policies, SOPs and systems
- Supports preparation and maintenance of departmental policies and SOPs that address the processing, analysis and reporting of safety information to ensure proactive surveillance of products in development
- Through coordination with Biomea Fusion GCP and PV Compliance team will provide appropriate representation during PV related regulatory inspections or internal quality assurance/corporate compliance audits
- Provides pharmacovigilance expertise to Biomea Fusion or CRO/Vendor staff when needed
- Ensuring SP/vendor oversight under the guidance of Executive Director Drug Safety and Pharmacovigilance by developing and implementing SP Oversight plans as required by Biomea Fusion PV SOPs
- In case of safety queries received from local Regulatory Authorities, under the direction of Head of Global Medical Safety Science inform relevant local and global personnel and respond in a timely manner to ensure tracking of the responses
- Participate in relevant crisis management activities within the scope of Biomea Fusion PV group
- Works closely with Executive Director Drug Safety and Pharmacovigilance and EU QPPV to be aware of all safety issues/concerns and provide consultation when needed
Education and Experience Requirements:
- BS/MS/RN and with 12+ years of experience or PharmD, PhD, MD 7+ years of experience in the pharmaceutical industry Solid knowledge and understanding of US and EU pharmacovigilance regulatory requirements and general regulatory expectations
- Extensive knowledge of biotechnology / pharmaceutical sector drivers and practices
- Demonstrated and excellent knowledge of relevant US and international regulations, guidance and initiatives governing both clinical trial and post-marketing safety environments
- Demonstrates advanced skill and keen insight in gathering, sorting, and applying key information to solve problems
- Demonstrates strong organizational and planning capabilities by managing time, workload, and resources of a function
- Leads and manages a functional area within a department to execute on team functional objectives that contribute to accomplishing common functional and departmental goals
- Capable of proactively assessing workload, trends, tasks, and priorities for cross-functional activity
- Highly proficient using Microsoft Office Suites. Knowledge of MS Teams is a plus.
- Collaborative, team-oriented mindset with strong verbal and written communication skills.
- Self-motivated, detail-oriented leader with exceptional organizational, leadership and interpersonal skills.
Equal Employment Opportunity:
At Biomea Fusion, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.