SDC (Statistics & Data Corporation)
Location
Hyderabad | India
Job description
SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances and positive work/life balance, we are able to attract some of the most talented people in the industry.
Job Summary: The Sr. Safety Specialist will support safety/pharmacovigilance (PV) operations activities including vendor oversight. They will assist in developing and implementing safety/PV guidelines and ensures the uniform and timely processing of adverse events and compliance within standard operating procedures (SOPs), Global, Federal, State, and local safety regulations. They will provide technical and safety-related regulatory assistance to study teams. Additionally, the Sr. Safety Specialist will be involved in risk-assessment work and will write, and/or sign-off on, documentation when created. Primary Responsibilities Applies Knowledge and Experience of Clinical Safety/PV to a wide range of clinical research studies in one or more therapeutic areas (e.g., Oncology, Ophthalmology) Coordinates and performs adverse event data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities to comply with protocol and regulatory specific requirements. Prepare for expedited reporting of SAEs, including preparation of analysis of similar events. Support the preparation of periodic safety reports in accordance with regulatory requirements and SOPs. Escalates potential patient safety issues to Sr. Leadership. Works closely with management and study teams to produce clear and concise communication of complex data. Acts as liaison to vendor for case processing activities and ensures adherence to processes and regulatory requirements. Supports safety database activities as needed. Seeks opportunities for continuous quality improvement. Other duties as assigned. The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified. Requirements Required Skills Ability to think analytically and process, evaluate, interpret, and synthesize scientific and medical data. Must possess ability to work and make decisions independently, understand complex medical information and be able to take initiative and lead projects and assignments. Excellent organizational, project and time management skills. Excellent working knowledge of ICH guidelines, US and EU pharmacovigilance regulatory requirements, and medical terminology. Strong technical writing, editing, and proof-reading skills. Strong vendor management skills. Knowledge of drug safety systems (e.g., ARISg, Argus, ABcube). Ability to meet multiple deadlines with a high degree of accuracy and efficiency. Self-motivated, detail oriented, and able to prioritize and plan effectively. Strong technical skills software skills (e.g., MS Word, MS Excel). Education or Equivalent Experience BS/BA in a scientific field or 6+ years of pharmacovigilance or safety case processing for clinical trials is required CRO experience preferred. Master's degree in scientific field and 3+ years of pharmacovigilance is preferred. Experience in and knowledge of drug safety databases (e.g., ARISg, Argus, ABcube Safety Easy), signal evaluation and risk management, aggregate data analysis, interpretation, synthesis, and authoring periodic aggregate safety reports (e.g., PBRERs, DSURs). Why SDC We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits. We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment. We strive to provide a place of belonging to our employees with fun and engaging activities from SDC's culture club. We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry. With a proven track record, SDC has been successfully executing client clinical programs since 2005. Take a look at how you can join our team!Job tags
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