Manager, Safety Scientist

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

📋 Description

• Provide support for designated compounds in collaboration with Product Safety Leads to carry out signal detection, safety data evaluation, safety risk assessment, responses to regulatory inquiries, and periodic reporting.

• Recognize, analyze, and assess safety data from relevant sources.

• Conduct signal detection and assessment accompanied by necessary documentation.

• Assist in developing data acquisition strategies and authoring safety assessments.

• Work alongside Safety Leads, scientists, pharmacoepidemiologists, and cross-functional teams on safety data evaluation and aggregate analysis.

• Prepare and present safety data for meetings with the Safety Management Team, Company Safety Committee, Safety Monitoring Committee, Data Monitoring Committee, and DSMB.

• Lead and facilitate safety team meetings, conveying pertinent safety information to stakeholders.

• Create, update, and review safety communication documents.

• Examine safety data and oversee patient safety in assigned clinical trials.

• Draft and review safety sections of protocols, IBs, ICFs, SAPs, TFLs, Medical Monitoring Plans, CSRs, and other study-related documents.

• Contribute to the preparation of aggregate reports, including PBRERs, DSURs, and PADERs.

• Write and review safety sections of regulatory submissions.

• Develop Storyboards and Briefing Books for interactions with health authorities.

• Assist in investigator training and reviews of Safety Management Plans.

• Analyze safety data and write safety sections for regulatory inquiries and periodic reports.

• Address safety-related questions from health authorities and IRBs/ECs.

• Support integrated benefit/risk assessments.

• Execute other departmental tasks as assigned by the manager.

⛳️ Requirements

• PharmD, RN, or PhD/MS in a medical field or biological science.

• A minimum of 2 years of experience as a Safety (Pharmacovigilance) Scientist.

• Experience in pharmaceutical product development.

• Familiarity with global regulatory requirements pertaining to pharmacovigilance.

• Experience working with a safety database like Argus for the retrieval of safety information.

• Intermediate knowledge of MedDRA and signal management systems.

• Advanced proficiency in Excel, PowerPoint, Word, and an electronic document management system such as Veeva.

• Knowledge of data mining and analysis tools like Spotfire and Power BI.

• Willingness to travel less than 10% of the time.

🏝️ Benefits

• Eligibility for an annual bonus plan for Non-Commercial roles.

• Discretionary equity awards.

• Employee Stock Purchase Plan.

• Medical coverage.

• Dental coverage.

• Vision coverage.

• 401(k) plan.

• FSA/HSA options.

• Life Insurance.

• Paid Time Off.

• Wellness programs.