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Job #03588

About our client Our client is an international CRO that provides full-service clinical trials management support for various therapeutic areas, such as oncology, cardiology and medical devices. Their vision is to become the preferred CRO for life science companies across the world. Due to growth, they are looking to hire an experienced Associate Director of Clinical Safety in either Southborough, MA or Ryebrook, NY. This is a great opportunity for someone looking for an exciting challenge! Position Location Associate Director, Clinical Safety Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee the activities of the Medical Affairs Group 2) Manage safety systems and capability building within Medical Affairs 3) Interface with different levels of staff within the organization, sponsors and vendors 4) Ensure that safety activities are completed according to project timelines 5) Manage project resources and monitor timeline compliance across multiple projects 6) Collaborate inter and intra-departmentally with staff for the design and implementation of strategies for the efficient production of quality technical documents 7) Assign staff to and coordinate resource distribution across projects 8) Participate in preparing technical documents for drug, biologic and device development (integrated clinical/statistical reports, efficacy/safety summaries, protocols, investigator brochures, IND, IDE applications, NDA, BLA and PMA submissions) 9) Ensure consistency of documents and processes across all offices 10) Participate in the management of endpoint adjudication activities 11) Assist Business Development with proposal development and presentations 12) Prepare and deliver presentations to potential clients detailing the company’s expertise in adverse event reporting and safety database systems 13) Prepare/review Pharmacovigilance metrics reports 14) Review, revise and propose SOP and incorporate medical knowledge for logic checks 15) Manage clinical trials and post marketing safety surveillance 16) Work with staff, clients and partners to identify/improve procedures for serious adverse event processing and reporting 17) Receive, assess, classify and process SAE reports received from clinical trial sites, sponsor representatives and CRAs 18) Manage and coordinate staff involved in global SAE reporting at all company offices 19) Adhere to regulatory guidelines and SOPs in processing serious adverse events 20) Manage and maintain safety database for all global projects 21) Review staff output for accuracy and completeness 22) Develop and implement a data management plan that enables system readiness for ad hoc reporting and or audits 23) Manage human resources activities (hiring, training, professional development, disciplinary action, performance evaluations, time off management, terminations) 24) Formulate and follow SOP 25) Perform additional duties assigned by the management Requirements 1) MD with safety and management experience 2) Minimum 5 years of clinical trial and post marketing experience including DMCs 3) Minimum 3 years management experience, preferably in the pharmaceutical or biotechnological sector 4) Experience in managing a Medical Affairs Group and safety systems 5) Experience in preparing and providing safety data for clinical trial reports, such as SUSARS, PSURs and Annual Reports, etc. 6) Strong knowledge of GCP, U.S., and ICH regulations and requirements regarding adverse events reporting for pre and post market 7) Ability to understand and interpret Safety Data results and evaluate medical coding 8) Ability to integrate clinical concepts and pathophysiology of disease with analysis