Drug Safety Associate III

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

📋 Description

• Process and evaluate serious adverse events from their receipt at Exelixis until case closure in the Argus database.

• Create queries, narratives, and writings related to adverse events.

• Conduct MedDRA coding for serious adverse events and other adverse events.

• Develop and update Exelixis MedDRA Coding Conventions.

• Establish and implement high standards for case quality review with guidance from the Drug Safety Physician.

• Schedule expedited safety report submissions in Argus as required.

• Train new safety personnel on Argus and case processing procedures.

• Collaborate with teams in Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Project Management.

• Execute Safety Study Lead responsibilities, including reviewing Investigator Brochures and study protocols, as well as contributing to IND Annual Reports.

• Create study-specific safety management plans using the Exelixis Drug Safety template.

• Develop, review, update, and harmonize drug safety forms and templates in alignment with clinical operations forms and templates.

• Conduct SAE reconciliation as stipulated by the safety management plan.

• Provide expertise in Drug Safety and ensure accurate documentation of safety data.

• Oversee and support outsourced vendors and drug safety study operational tasks from initiation through to closeout.

• Identify and escalate issues that may have a broader impact.

• Implement solutions to address task-related challenges.

⛳️ Requirements

• BS/BA degree in Nursing, Pharmacy, or a related clinical discipline with a minimum of 7 years of relevant experience; or an MS/MA degree with at least 5 years of related experience; or a PhD with no prior experience or an equivalent combination of education and experience.

• Certification in the assigned area may be required.

• Experience in processing clinical trial and spontaneous adverse events.

• Familiarity with the biotechnology/pharmaceutical industry.

• Understanding of the regulatory framework governing patient safety.

• Experience in the biotech/pharmaceutical sector and/or oncology is preferred.

• Proficiency in using the Argus Safety Database is preferred.

• Capacity to process and evaluate serious adverse events and other adverse events.

• Knowledge of MedDRA coding.

• Ability to adhere to drug safety case processing and reporting protocols.

• Strong analytical problem-solving skills.

• Excellent organizational and planning abilities.

• Effective verbal and written communication skills.

• Capability to collaborate effectively with team members.

• Strong interpersonal skills.

• Ability to identify and escalate issues as necessary.

• Proficient in training on procedures, tasks, and tools; may provide mentorship to junior team members.

🏝️ Benefits

• 401k plan with generous company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• Discretionary annual bonus program.

• Opportunity to purchase company stock.

• Long-term incentives.

• 15 accrued vacation days in the first year.

• 17 paid holidays, including a company-wide winter shutdown in December.

• Up to 10 sick days throughout the calendar year.

• Necessary equipment, including dual monitors and ergonomic chairs.

• Disability accommodation support during the recruiting process.