Manager - Drug Safety Operations

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 Manager - Drug Safety Operations is responsible for overseeing departmental Operations to ensure timely and fully compliant completion of deliverables including, but not limited to, the submission of Periodic Adverse Drug Experience Reports, adverse case exchange with licensing partners, expedited reporting to Health Authorities. This individual interfaces with Safety Systems staff in implementing a strategy to support the administration and maintenance of the Drug Safety database including data management activities and ad hoc reporting capabilities to meet the clinical safety and post-marketing operational business requirements.

* Acts as team lead in pharmacovigilance activities relate d to clinical study support relating to safety . * Coordinates the timely completion and submission of required reports to health authorities and business partners . * Ensure s all adverse event reports made to Acorda or contracted safety vendor acting on behalf of Acorda, are triaged, scheduled, processed and reported according to Acorda SOPs and Work Instructions . * Assists with creating p olicies, SOPs, work instructions, forms and templates for efficient and effective processing of ICSRs and aggregate reports . * Ensures Acorda procedures are in compliance with all ICH-GCP guidelines, F ederal R egulations, industry best practice, and agreements with l icensing p artners and /or regulatory authorities . * Assist s in the design of workflow practices and t rack s all cases to ensure adherence to processing timelines . * Identif ies , select s and manage s relationships with CROs for the PV day-to-day project management and related case-processing activities. * Works with the management to review Acorda DSRM c ompliance data. * Assists in developing and maintaining safety data exchange agreements and manage s relationships with partners. * Manages relationships and daily operational issues with licensing partners. * Collaborates with Drug Safety Medical Directors to ensure that medical review and documentation is provided for assigned cases and is in accordance with Acorda SOPs and Work Instructions. * Provide s input on protocol development, as well as the development of CRFs and Consent Forms. * Initiates new safety projects, including the development of study-specific Safety Management Plans, Safety Charters, Reconciliation Plans and other study related documents . * Contributes to writing of late case investigations/ identifying root cause including developing and implementing CAPAs (corrective and preventive actions). * Assist s in safety management activities for Investigator Initiated Trials (IITs), including the review and implementation of appropriate safety reporting processes . * Undertakes ongoing performance review, feedback and development of staff. * Assists with talent recruitment and leads a highly motivated, efficient and effective team. * Responsible for training and mentoring safety systems associates on the Drug Safety Operations team .

Education and/or Experience : * Bachelors degree in health science or related field preferred, with a minimum of three to five years of clinical practice . * Masters degree in health science or related field preferred. * One of the following is required: RN, RPh, PharmD, PA or MPH. * Minimum of s ix to eight years related experience in a biotechnology or pharmaceutical company. * Minimum of five years drug safety experience . * W orking knowledge of ICH and GCP Guideline s and US CFR 314.80, 312 .32; MedDRA and WHO DRUG dictionaries . Familiarity with European regulations and regulatory authorities is desirable. * Prior supervisory experience preferred. Supervisory Responsibilities: * This individual supervis es a team of Drug Safety Specialists . Qualifications: * Solid understanding of drug development process and drug safety regulatory requirements, including knowledge of safety reporting in clinical trials, post-marketing surveillance, case processing and reporting to Regulatory Authorities worldwide. * Prior e xperience with operational aspects of Clinical trials and post-marketing ICSR reporting required. * Successful track record of mentoring (or managing) staff and projects * Ability to effectively represent Safety Operations on multi-disciplinary teams; ability to evaluate and analyze procedural gaps. * Experience with managing vendors, partners and CROs highly preferred. * Computer Skills : * Must be p roficient in MS Office Suite . * Prior safety database experience in Argus or other platform is preferred . Certificates, Licenses, Registrations: none required * Other Skills and Abilities : * Excellent written and verbal communication skills , including presentation skills . * Fluent in medical terminology . * Ability to prioritize and multi-task successfully in a fast paced environment. * Ability to interpret and follow regulatory guidelines . * Ability to react constructively in a high-energy and fast paced environment. * Excellent project management skills with the ability to align internal and external resources. * A bility to work autonomously, as well as act as a strong team player.