Job Description

Company OverviewTango Therapeutics is a biotechnologycompanydedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer.Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at critical targets in cancer.This includes expanding the universe of precision oncology targets into novel areas such as tumor suppressor gene loss and their contribution to the ability of cancer cells to evade immune cell killing.The Tango labs and offices are located at201 Brookline Avenue, in the Fenway area of Boston, Massachusetts.SummaryThe Associate Director, Pharmacovigilance Scientist, reporting to the Senior Director, Drug Safety, plays a pivotal role, partnering closely across the organization to evaluate drug safety data, manage adverse event signals and author regulatory safety reports across the product lifecycle from first-in-human studies through global registration and commercialization.This role is responsible for high-quality safety surveillance activities including aggregate report production, safety governance meeting coordination, safety signal detection and assessment and safety risk management activities for assigned Tango products.This role is accountable for proactively and continuously evaluating and clearly communicating benefit-risk profiles across the product lifecycle—ensuring alignment with global regulatory expectations, pharmacovigilance standards, and industry best practices, while enabling confident, data-driven development and commercialization decisions.Your RoleLead and oversee ongoing safety surveillance (including signal detection activities and literature reviews) for assigned programs, ensuring compliance with global regulatory requirements and company objectivesContribute as the safety subject matter expert for assigned programs, driving benefit-risk assessment, signal detection, risk management, and safety governance in partnership with drug safety leadership and cross-functional teamsAuthor and contribute to key safety deliverables, including DSURs, PSURs/PBRERs, Safety Assessment Reports for potential signals/risks, Reference Safety Information (RSI) and ADR in the DCSI/CCSIProvide safety review and contribute to various clinical trial documents including but not limited to protocols, informed consent forms, Investigator’s BrochureProvide analyses and presentation of safety data and messages to define the product risk profile and inform risk managementPartner with the Pharmacovigilance Operations team to enhance, and maintain a scalable global drug safety and pharmacovigilance framework supporting both clinical development and post-marketing activitiesContribute to the development and optimization of new tools and processes by applying industry best practices, emerging methodologies, and evolving trends in pharmacovigilance, signal detection, and benefit-risk managementContribute to the planning and conduct of safety committee and data monitoring committee activitiesCollaborate with Partner for co-development or co-marketing, when applicable, with regards to drug safety related activitiesEnsure compliance with regulatory guidelines and internal processes and procedures in preparation of audits and inspectionsParticipate in audit and inspection activities, as requiredMaintain up-to-date knowledge of relevant current FDA, ICH guidelines, EU PV regulations and other PV legislation globallyWhat You Bring8+ years of drug safety and pharmacovigilance experience within the biotechnology and/or pharmaceutical industry with at least 3 years in pharmacovigilance sciencesBachelor’s degree in a scientific or health care related discipline required, advanced degree (MS, PharmD, PhD, MD, RN) strongly preferredStrong drug safety and regulatory knowledge, ideally in oncologySkilled in signal detection processes and managing safety information across the product life cycleExperience authoring aggregates safety reports including DSURs, PSURs/PBRERs and safety-related sections of clinical trial documents such as IB and RSIDemonstrated expertise in global PV regulations, GVP and ICH guidelines, safety systems and drug development processesAbility to translate complex safety data into actionable recommendations and identify alternative solutions for regulatory and clinical decision-making.Experience in regulatory submissions for marketing license applications in the US and in EU preferredSelf-motivated, flexible, able to prioritize, multitask and work in a fast-paced and demanding environment.Strong organizational and project management skillsExcellent communication and cross-functional collaboration skillsWe are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.Salary range $161,600—$242,400 USD

Job Tags

Similar Jobs