Senior Drug Safety Specialist

Acorda Therapeutics is a publicly traded (NASDAQ: ACOR) biotechnology company whose mission is to develop therapies that restore neurological function and improve the lives of people with neurological disorders.

The Senior Drug Safety Specialist is responsible for overseeing all aspects of adverse event processing and reporting for assigned investigational and marketed products, while assisting management in establishing and implementing departmental strategy. This individual serves as a liaison to external contracted safety providers and company associates for safety related issues, working in close collaboration with colleagues from Clinical Operations, Regulatory Affairs, Quality and Medical Affairs.

* Completes data entry of individual case safety reports (ICSRs) from clinical trials and post marketing sources. * Conducts complete clinical review of all domestic and foreign adverse events reports for all Acorda investigational and marketed products. * Ensures consistency in the initial evaluation and assessment of adverse event reports and source documentation for completeness, accuracy and legibility. * Performs active follow-up, including both written and verbal communication with healthcare professionals and consumers. * Interprets source documentation including relevant medical conditions, lab results and procedures to compile complete and accurate narrative summaries. * Exercises judgment and use of knowledge of FDA and ICH guidelines and product labeling in performing initial case assessment for seriousness, expectedness, causality, listedness and reporting requirements. * Assists Quality, Standards and Training team in tracking late reports to licensing partners and regulatory health authorities, including maintaining documentation of root cause analysis and correction action. * Reviews all medical and drug terminologies according to project specific coding conventions, Package Insert, Investigator Brochure and Company Core Data Sheet. * Produces Clinical Safety Queries as needed for clarification of adverse events originating from an Acorda sponsored clinical trial. * Serves as a Safety Liaison contact to other departments and Acorda licensing partners. * Interacts on a regular basis with Clinical Project Mgrs, Case Processing Mgrs and Medical Affairs to identify process improvement strategies and communicate project status updates. * Interacts on a regular basis with contract drug safety vendor (data management, case processing, call center, etc) to resolve safety-related issues. * Assists the Director with the development and periodic review of department SOPs, WIs, SAE Report Forms. * Reviews aggregate adverse event and concomitant coding datasets from the Clinical Database in support of interim analysis or final database lock. * Assists in the preparation and review of periodic adverse drug experience reports for regulatory health authorities.

* Education and/or Experience: * Bachelor’s degree in Nursing, Pharmacy or a health-care related field required. * Minimum of four to six years drug safety experience in a biotechnology or pharmaceutical company. * Working knowledge of ICH/GCP Guidelines and US CFR 314.80, 312.32; MedDRA and WHO_DRUG dictionaries. * Familiarity with safety databases, data entry platforms, adverse event data collection process, case processing unit, call center, product complaints, 15-day safety alerts, submissions of safety updates to the FDA, Pharmacovigilance Safety Data Exchange Agreements, Risk Evaluation and Mitigation Strategies, Medications Guides, pre-approval process and post-marketing commitments to FDA, FDA Industry Guidelines, ICH Guidelines, Regulatory Approval Process and Drug Development. * Experience participating in pharmacovigilance audits and regulatory inspections is preferred. * Qualifications: * Working knowledge of cGXPs. * Strong knowledge of Demonstrated Good Documentation Practices. * Fluent in medical terminology. * Computer Skills: * Must be proficient in MS Office Suite. * Certificates, Licenses, Registrations: * At least one of the following: LPN, RN, RPh, PharmD, P.A. or MPH required. * Other Skills and Abilities: * Excellent written and verbal communication skills. * Ability to interpret and follow regulatory guidelines. * Ability to manage both day-to-day operations as well as project work in a fast paced environment. * Ability to work both independently and in a collaborative team setting. * Must demonstrate a keen attention to detail and timelines.