Director, Safety Scientist

BeiGene

92d • $179,800 - $239,800

About The Position

The Director, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages clinical and scientific expertise to lead the detection of safety signals, evaluation of safety data, assessment of safety risks, responses to regulatory inquiries, and regulatory-required periodic reporting. Physicians in this role are also expected to provide medical safety assessment. In this role, you will apply effective prioritization, critical thinking, and judgment-based decision making to execute these key deliverables in compliance with global regulations and internal processes. Effective communication and influence with internal and external stakeholders are important capabilities for this role. This role represents GPS Safety Science internally and externally at a global level and functions as an authoritative and professional member of relevant teams.

Requirements

• PharmD, NP, RN, or PhD in a medical field or biological science.
• 8+ years of experience as a Safety (Pharmacovigilance) Scientist.
• MD (or internationally recognized equivalent) plus accredited residency or comparable level of post-medical school clinical training.
• 4+ years of clinical experience with patients in a relevant therapeutic area specialty.
• 6+ years of pharmaceutical/biotechnology industry experience in Safety Science, Clinical Development, or Clinical Research.
• Advanced knowledge working with a safety database (i.e., Argus).
• Advanced knowledge of MedDRA and signal management system.
• Advanced application capability with Excel, PowerPoint, Word, and electronic document management system (i.e., Veeva).
• Demonstrated ability to prioritize and manage multiple deliverables simultaneously.
• Demonstrated leadership, organizational and administrative skills.

Nice To Haves

• Prior matrix management team experience.
• Clinical knowledge of various disease states, drug effects, human physiology and pharmacology.
• Prior experience with Regulatory Agency interactions.
• Pharmaceutical product development experience, including individual study design and filing plans.
• Experienced in global regulatory requirements for pharmacovigilance.

Responsibilities

• Lead the identification, analysis, and evaluation of safety signals from multiple internal and external data sources.
• Define data acquisition strategy, methodology, and approach for safety evaluations.
• Perform analysis of safety data and lead authoring of safety assessment.
• Drive collaboration with PSLs, Safety Scientists, Pharmacoepidemiologists, and cross-functional personnel.
• Lead execution of signal assessment strategy and assess potential impact on the product safety profile.
• Prepare and present safety data at safety governance meetings.
• Communicate relevant safety information to core team, business partners, and key stakeholders.
• Lead the development, update, and review of safety communication documents.
• Lead the review of safety data and monitor the safety of patients on allocated clinical trials.
• Lead the authoring and review of safety sections of regulatory submissions.
• Lead analysis of safety data and author relevant safety sections of global regulatory inquiries and periodic reports.
• Contribute to integrated Benefit/Risk assessments.
• Promote and advance the field of pharmacovigilance.
• Contribute to continuous employee development programs.
• Identify and develop innovative approaches to improve organizational effectiveness.

Benefits

• Medical, Dental, Vision insurance.
• 401(k) plan.
• Flexible Spending Account (FSA) / Health Savings Account (HSA).
• Life Insurance.
• Paid Time Off.
• Wellness programs.
• Employee Stock Purchase Plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree