AMAG is a biopharmaceutical company focused on bringing therapeutics to market that provide clear benefits and help improve people’s lives. Our employees work to develop and deliver important therapeutics, conduct clinical research in areas of unmet need and create education and supportprograms for the patients and families we serve. AMAG's products support the health of patients in the areas of maternal and women's health, anemia management and cancer supportive care. Through CBR®, we also help families to preserve newborn stem cells, which are used today in transplant medicine for certain cancers and blood, immune and metabolic disorders, and have the potential to play a valuable role in the ongoing development of regenerative medicine.
AMAG's core values -- accountable, collaborative, transparent, sense of urgency, and results focused -- provide an important framework for who we are and how we operate. Our values are also foundational to the way we do business and are key to how we execute on our five year strategic plan 2015-2020: Growing, Building, Together. We take a patient-centric approach to continuing to grow our current products through meaningful investment in research toexpand the utility of these products and a strong commitment to patients and support programs.
In addition, we seek to build our product portfolio with additional therapeutics that could benefit from our business and clinical expertise. The successful execution of our strategy hinges on a talented and motivated team of employees who work together to make our plans a reality. Every day, the people atAMAG aim higher, devoting our passion and perseverance to finding new and better ways to support the health of patients and families.
Perform the assessment of medical safety information including single cases and aggregate safety data for AMAG’s developmental and marketed products. Provide signal detection and benefit/risk management expertise and contribute to the development of pharmacovigilance strategies for monitoring thesafety profile of the company’s products. Provide pharmacovigilance expertise to and work collaboratively with external partners and other functions across AMAG, including Clinical Development, Regulatory Affairs, and Medical Affairs to ensure that drug safety communications are accurate, complete and consistent
Duties & Responsibilities:
To include but not limited to the following:
• Conduct thorough medical review of individual case safety reports (ICSRs)
• Based on all available medical information determine the case reportability criteria, and the assessment of seriousness, expectedness and causality. Request missing medical information as needed
• Review aggregate safety data and contribute to the preparation of the medical content of periodic reports (including PSURs, DSURs) and ad-hoc reports.
• Participate in regular and ad-hoc cross functional safety review teams. Represent pharmacovigilance on other multi-departmental projects
• Prepare and ensure the quality, consistency, and timely delivery of safety information for regulatory submission documents (including IND and NDA submissions)
• Author relevant sections of responses to safety related health authority requests
• Author and/or review relevant sections of various clinical documents including Investigator’s Brochures, clinical protocols, safety management plans, study reports, and integrated analyses
• In close collaboration with the Sr. Medical Director for PV, develop and maintain general safety signal management methodologies and product specific signaling strategies
• Guide and inform pharmacovigilance colleagues on medical assessment, signal detection and safety risk management practices
• Identify opportunities and manage continuous improvement initiatives as related to medical assessment of pharmacovigilance data
• Actively interact with external customers and service providers including AMAG business partners, CROs, system vendors and the call center
• Develop and/or update relevant procedural documents including SOPs, Work Instructions, conventions, forms or templates
• Provide medical safety expertise for internal and external audits and regulatory authority
• M.D. degree required
• Minimum 3-5 years of experience in pharmacovigilance including medical review, signaling and safety risk management
• Minimum 2 years of experience in clinical practice or in academic medicine
• Demonstrated ability to analyze and present complex pharmacovigilance data
• Experience authoring medical evaluations and contributing to regulatory submissions
• Strong competency in understanding the scientific background of disease mechanisms and medical therapies
• Understanding of global pharmacovigilance regulatory requirements and guidance documents
• Ability to influence decision making around multifaceted issues involving medical safety
• Proficiency in the use of MS Office and other relevant cloud based applications
• US Board Certified or eligible preferred
• Experience in global drug development including epidemiology, clinical research, medical affairs or other relevant fields
• Excellent communication and organizational skills
• Demonstrated ability to think strategically and communicate complex issues clearly