Drug Safety Associate III

🔥 15 hours ago

🇺🇸 United States – Remote

💵 $130.5k - $185k / year

⏰ Full Time

🟠 Senior

🔴 Lead

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Exelixis

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1994

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $65M Post-IPO Equity on 2012-02

Healthcare • Biotechnology • Pharmaceuticals

Exelixis is a biotechnology and pharmaceutical company focused on developing cancer treatments through innovative research and development. The company is committed to advancing oncology by creating impactful cancer medicines, including biotherapeutics and small molecule therapies. Exelixis places a strong emphasis on clinical trials, collaborations, and a diverse range of treatment modalities, aiming to provide hope to cancer patients. Additionally, Exelixis is dedicated to sustainability, diversity, and community support, as reflected in their corporate values and practices.

📋 Description

• Process and assess serious adverse events from receipt at Exelixis through case closure in the Argus database • Generate queries, narratives, and ASE writings • Perform MedDRA coding of serious adverse events and adverse events • Develop and revise Exelixis MedDRA Coding Conventions • Define and apply high standards for case quality review with support from the Drug Safety Physician • Schedule expedited safety report submissions in Argus as needed • Train new safety staff on Argus and case processing • Collaborate with Clinical Development, Clinical Operations, Data Management, Regulatory Affairs, and Project Management • Perform Safety Study Lead activities, including reviewing Investigator Brochures and study protocols and participating in IND Annual Reports • Develop study-specific safety management plans from the Exelixis Drug Safety template • Develop, review, update, and harmonize drug safety forms and templates with clinical operations forms and templates • Perform SAE reconciliation as required by the safety management plan • Provide Drug Safety expertise and ensure quality documentation of safety data • Support and oversee outsourced vendors and drug safety study operational activities from study start-up through closeout • Identify and escalate issues with broader impact • Implement solutions for task-related challenges

🎯 Requirements

• BS/BA degree in Nursing, Pharmacy, other clinical, or related discipline and a minimum of 7 years of related experience; or MS/MA degree and a minimum of 5 years of related experience; or PhD and 0 or more years of related experience; or equivalent combination of education and experience • May require certification in assigned area • Experience in clinical trial and spontaneous adverse event processing • Knowledge of the biotechnology/pharmaceutical sector • Knowledge of the regulatory framework governing patient safety • Experience in the biotech/pharmaceutical industry and/or oncology preferred • Experience using the Argus Safety Database preferred • Ability to process and assess serious adverse events and adverse events • MedDRA coding knowledge • Ability to follow drug safety case processing and reporting procedures • Analytical problem-solving ability • Organizational and planning capabilities • Clear verbal and written communication skills • Ability to work collaboratively with team members • Good interpersonal skills • Ability to identify and escalate issues • Ability to train on procedures, tasks, and tools; may mentor 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