Assoc. Safety Medical Director

Role Summary

Supports DSPV Operations in oversight and medical review of individual case safety reports for Neurocrine's investigational and marketed compounds. Performs pharmacovigilance activities, such as aggregate reports and signal detection. Contributes to DSPV Quality and Compliance by providing medical leadership to PV vendor staff.

Responsibilities

• Perform medical review of individual case safety reports, including summarization, coding, seriousness, expectedness and company causality assessment of investigational and/or marketed products
• Provide vendor oversight for medical functions including but not limited to sample-based quality check of vendor’s activities, participation in vendor functional and governance meetings and collaboration with Neurocrine internal safety operations and surveillance teams
• Provide ongoing guidance, training and mentorship to PV vendor medical teams.
• Perform safety signal management related activities to detect, analyze, and investigate safety signals
• Perform aggregate safety data review and interpretation to support safety evaluations
• Support authoring, review, and provide input for drug-safety related regulatory reports and clinical study documents
• Utilize MedDRA terminology and perform/oversee data review using SMQs, FMQs and other MedDRA grouping as required
• Support the preparation and review of aggregate reports such as PADER, PBRER, DSUR etc
• Participate in developing processes and conventions for DSPV operations activities
• Participate in internal and external inspections and represent DSPV operations from a medical perspective
• Contribute to development of procedural documents such as SOPs, WIs, and vendor safety medical operational process documents
• May serve as the Safety Physician Lead for designated indications or clinical studies
• Support DSPV medical safety compliance activities as required
• Other duties as assigned

Qualifications

• Medical Doctor (M.D), M.B.B.S degree or equivalent AND 2+ years of experience in pharmacovigilance in a pharmaceutical (preferably) or biotechnology company with experience in medical review and signal management (e.g., signal detection, evaluation, assessment) or relevant experience OR
• Board certification
• Excellent oral, written and presentation skills
• Strong attention to detail is critical
• Strong leadership skills and ability to manage several internal and external stakeholders
• Excellent teamwork and interpersonal skills are required
• Excellent problem-solving, analytical thinking skills
• Sees broader picture, impact on multiple departments/divisions
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Excellent organizational and project management skills
• Mastery of safety databases (ARGUS preferred) and safety coding dictionaries (e.g., MedDRA, WHODRUG)
• Ability to lead and conduct individual safety case report processing, including triage, medical review, safety data summarization and analysis and signal management
• Proficiency in signal management databases such as Empirica preferred
• Excellent technical drug safety writing skills for documents such as aggregate reports
• Knowledge of and ability to apply international regulatory authority regulations (especially FDA, and EU/EEA)
• Knowledge of and ability to apply pre- and post-marketing drug safety standards