Sr. Specialist, Safety

Role Summary

Support pharmacovigilance (PV) Operations activities including vendor oversight, case processing and submission. Develops and implements PV guidelines and ensures the uniform and timely processing of adverse event for NBI compounds in clinical development and post-approval. Ensures compliance with standard operating procedures and global regulations. The Sr. Specialist, Safety will work independently, with limited supervision. This position will require onsite participation at a minimum of 3 days a week, with the possibility of more based on business needs.

Your Contributions

• Provide oversight of outsourced safety-related functions
• 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 standard operating procedure
• Support signal detection and evaluation activities in accordance with SOPs and guidelines
• Participates in developing DSPV Operations SOPs and guidelines and provides staff training
• Acts as liaison to vendor for case processing activities and ensures adherence to processes and regulatory requirements
• Develops study specific case processing reference information for staff and provides training
• Supports safety database activities as needed
• Other duties as assigned

Requirements

• BS/BA in a scientific field or RN degree and 4+ years of pharmacovigilance or clinical and/or medical research or equivalent experience. Experience in and knowledge of drug safety databases (e.g., ARISg, Argus), signal evaluation and risk management, aggregate data analysis, interpretation and synthesis, and authoring periodic aggregate safety reports (e.g. PBRERs, DSURs) and RMPs. OR
• Master‚Äôs degree in scientific field and 2+ years of pharmacovigilance or clinical and/or medical research or equivalent experience. Experience in and knowledge of drug safety databases (e.g., ARISg, Argus), signal evaluation and risk management, aggregate data analysis, interpretation and synthesis, and authoring periodic aggregate safety reports (e.g. PBRERs, DSURs) and RMPs. OR
• PharmD or PA without experience
• Strong vendor management skills
• Ability to evaluate, interpret and synthesize scientific data
• Strong knowledge of ICH guidelines, US and EU pharmacovigilance regulatory requirements
• Knowledge of drug safety systems (e.g. ARISg and Argus)
• Strong knowledge of current PV practices
• Vendor management experience preferred
• Expertise in clinical trial and post-marketed PV
• Understands key business drivers and uses this understanding to accomplish work
• Has strong understanding of processes, procedures and systems used to accomplish the work and recognizes downstream impact on other functional areas
• Proficient with tools and processes that support work conducted by functional area
• Ability to work as part of a team; may train lower levels
• Excellent computer skills
• Strong communications, problem-solving, analytical thinking skills
• Detail oriented yet can see broader picture for department
• Ability to meet multiple deadlines, with a high degree of accuracy and efficiency
• Strong project management skills
• Team player with ability to function in a multi-disciplinary environment
• Self-motivated, detail oriented, and able to prioritize and plan effectively
• Strong technical skills software skills (i.e., MS Excel)