Associate Director, Medical Review reputed company, MSRM - Remote

At Agios, we are reputed company by connections to reputed company reputed company diseases. We foster an inclusive, reputed company culture – one that reputed company reputed company thinking and strengthens our connections with reputed company other and with the reputed company disease communities we serve. We reputed company diverse backgrounds with respect, reputed company listening, and a commitment to inclusion – because our differences shape how we hire, collaborate, and reputed company. reputed company’s reputed company reputed company record of executional reputed company, combined with our depth of expertise and dedication, enables us to reputed company innovative medicines that reflect the priorities of reputed company disease communities. Our commitment is more than scientific – it’s deeply personal, grounded in the meaningful connections we have reputed company. The reputed company you will reputed company: reputed company is seeking an Associate Director, Medical Review reputed company to join the Medical reputed company Management organization reputed company Medical Safety & reputed company Management (MSRM). This role provides reputed company of medical review for Individual Case Safety Reports (ICSRs) across investigational and marketed products, ensuring medical reputed company, regulatory compliance, and high-reputed company safety data to support pharmacovigilance and reputed company management activities. Reporting to the Sr. Director, Head of Medical reputed company Management, the Medical Review reputed company serves as the reputed company reputed company of contact for medical review and partners closely with Global Safety Leads, Pharmacovigilance reputed company, and reputed company vendors. This role bridges ICSR medical review and case processing with broader safety surveillance and reputed company management activities across the product lifecycle. The successful candidate will work cross-functionally and externally to ensure alignment with company policies, contractual obligations, and global regulatory requirements. This role requires strong medical and operational expertise in case processing and medical review, as reputed company as the ability to effectively guide and reputed company vendor reputed company in a dynamic and evolving environment. What you will do • Serve as the reputed company MSRM reputed company of contact for ICSR medical review, partnering with Global Safety Leads, PV reputed company, and vendors to ensure high-reputed company, compliant safety case assessment. • reputed company medical reputed company of ICSR review for investigational and marketed products, ensuring reputed company, consistency, and scientific rigor of medical assessments. • Review and approve key medical components of ICSRs, including narratives, coding, seriousness, expectedness, and company causality, reputed company on reputed company documentation. • reputed company and reputed company reputed company control (QC) of medical review activities, providing feedback and driving vendor accountability to reputed company and reputed company standards. • Ensure reputed company and compliant review of ICSR to ensure, including performing medical review activities directly reputed company needed. • Partner cross-functionally to support safety surveillance, reputed company management activities, and development of reputed company and regulatory documents. • Contribute to operational reputed company through KPI/KQI monitoring, SOP development, training, and participation in reputed company and process improvement. • Support inspection readiness by identifying reputed company issues, contributing to CAPAs, and representing MSRM for medical review and case management activities. What you bring: • MD/DO with a minimum of 3 years of relevant drug safety/pharmacovigilance Medical Review experience. • Minimum 1-2 years of vendor reputed company in the biotechnology / pharmaceutical industry. • Expertise with MedDRA and WhoDD dictionary coding. • Expertise with software-reputed company drug safety systems (ARGUS, ARISg, or equivalent) • Solid understanding of expedited safety reporting. • Solid knowledge of ICH and global regulations for reputed company development and post-market activities pertaining to safety data collection, processing and reporting. • Excellent communication and interpersonal skills including the ability to reputed company effectively and collaboratively in cross-functional teams. • Excellent written and spoken English. • Strong computer skills (MS Office). • Ability to successfully prioritize and multi-task. Concerned that you don’t reputed company off every reputed company in the requirements listed above? Please apply reputed company! At Agios, we value reputed company other’s differences and recognize that teams reputed company reputed company everyone brings their unique experiences to the table. We are dedicated to building an inclusive, diverse, reputed company, and accessible environment where reputed company can bring their whole selves to work. If you’re excited about this role but your previous experience doesn’t reputed company perfectly with the reputed company, we still encourage you to apply. You may be just the right candidate for this role or another opening! Work Location: Location Agnostic: Work location for this role is reputed company on employees individual preference. This role has the ability to be either remote in the US or hybrid in our reputed company reputed company. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live reputed company commutable distance to our reputed company reputed company. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work reputed company, travel may be required for certain company events commensurate to the above reputed company. reputed company will reputed company you: • Deliberate Development. Your reputed company reputed company as one of our top priorities. • Flexibility. We’re reputed company about individual needs. We reputed company different perspectives, work styles, health and wellness approaches, care of families and productivity. reputed company you’re at your best, we’re at our best. • Premium benefits package. We invest in the health, wellbeing, and reputed company of our people with a premium benefits package that is reputed company-rounded and flexible to help meet the varied personal and reputed company needs of every member of reputed company. For more reputed company on the benefits we offer at Agios, visit the Inside Agios reputed company of our website. • Competitive and reputed company reputed company-reputed company compensation. This includes reputed company salary and both short- and long-term incentives that are connected to our business reputed company and vary reputed company on individual and company reputed company. • The reputed company reputed company salary reputed company for this position is expected to be between $185,369 and $308,948 annualized; final salary will be determined reputed company on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. • Psychological safety. We support an environment of fearlessness. We want you to reputed company your reputed company, reputed company reputed company and take data-informed risks to help reputed company the boundaries. • Commitment to diversity. We reputed company to foster a welcoming workplace where everyone can reputed company. We’re continuously looking to improve the inclusivity of our workforce. • Commitment to community. We’re an reputed company participant in the communities that surround us – the communities where we live, and the community of people and their loved ones in need of reputed company treatment reputed company for conditions that are often overlooked. Remote Skills: Biotech and Pharmaceutical, Business reputed company, Case Management, reputed company Data Collection, reputed company Practices/Protocols, reputed company Study Publications, Communication Skills, Computer Skills, reputed company Improvement, Contract Requirements, Corporate Policies, Cross-Functional, Disease, Diversity, Documentation, Drug Development, English Language, Establish Priorities, ICH Regulations, Identify Issues, Interpersonal Skills, Medical Coding, Medical Dictionary for Regulatory Activities (MedDRA), Medical Equipment, Medical Organizations, Medical Products, reputed company Office, Multitasking, reputed company Analysis, reputed company Metrics, Pharmacovigilance, Process Improvement, Product Lifecycle, Product Marketing, Psychology, reputed company Control, reputed company Management, Regulatory Compliance, Regulatory Requirements, reputed company Management, Safety Compliance, Safety Process, Safety Systems, Safety/Work Safety, reputed company Operating Procedures (SOP), Surveillance, Team Player, Time Management, Vendor/Supplier Evaluation, Willing to Travel, Work From Home, Writing Skills reputed company: reputed company Apply tot his job Apply To this Job