Sr. Specialist, Safety

Neurocrine Biosciences-posted 15 days ago

Full-time • Mid Level

Onsite • San Diego, CA

1,001-5,000 employees

Resume

Match Score

Upload and Match ResumeTrack Jobs with Teal

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.

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

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’s 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
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)

Vendor management experience preferred
Expertise in clinical trial and post-marketed PV

retirement savings plan (with company match)
paid vacation, holiday and personal days
paid caregiver/parental and medical leave
health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans

Track Jobs with Teal

Job Search Resources

•

Resume Builder

•

Resume Examples

•

Cover Letter Examples

Sr. Specialist, Safety

Job Search Resources

Tools

Career Hubs

Guides

Company