Director – Safety Scientist

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide assistance for designated compounds alongside Product Safety Leads (PSLs)

• Spearhead the identification of safety signals, assessment of safety data, and evaluation of safety risks

• Conduct analyses of safety data and compose safety assessments

• Foster collaboration with PSLs and cross-functional teams for comprehensive evaluation of safety information

• Oversee the preparation and presentation of safety data during governance meetings

• Timely communicate pertinent safety information to stakeholders

• Direct the writing and review of safety communication documents

• Assist in the review of safety data and monitor patient safety in assigned clinical trials

• Draft safety sections of regulatory submissions and oversee Safety Management Plans

• Lead the analysis of safety data for global regulatory inquiries and periodic reporting

• Advocate for ongoing enhancement in organizational efficiency and productivity

⛳️ Requirements

• PharmD, NP, RN, or PhD in a medical field or biological science

• Over 8 years of experience as a Safety (Pharmacovigilance) Scientist

• More than 4 years of clinical experience with patients in a relevant therapeutic area specialty

• At least 6 years of experience in the pharmaceutical/biotechnology industry within Safety Science, Clinical Development, or Clinical Research

• Proficient knowledge in utilizing a safety database (e.g., Argus)

• In-depth understanding of MedDRA and signal management systems

• Advanced proficiency with Excel, PowerPoint, Word, and electronic document management systems (e.g., Veeva)

• Previous experience in matrix management teams

• Prior interaction experience with Regulatory Agencies

🏝️ Benefits

• Medical

• Dental

• Vision

• 401(k)

• FSA/HSA

• Life Insurance

• Paid Time Off

• Wellness