Associate Director, Safety Reporting

Job not on LinkedIn

🔥 3 hours ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $162.4k - $203k / year

⏰ Full Time

🟠 Senior

👔 Director

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BeOne Medicines

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Support and manage the function, maintenance, and validation of data and analytics solutions, including business intelligence and automation • Manage changes to data and analytics solutions under the change control policy, including configuration changes and system upgrades • Manage development and validation of aggregate safety reports • Contribute to ad hoc report specification, development, validation, and implementation • Maintain required validation documents • Manage timely flow of business intelligence information to users • Train departmental staff on reporting solutions and Safety Systems • Communicate information and project status and collaborate on problem resolution • Provide leadership and technical expertise as a team member • Serve in a consultative role to resolve safety system issues and interface with other pharmacovigilance tools • Participate in implementation of Safety informatics systems, including Safety Data Mart, signal detection and surveillance tools, and reporting systems • Assist with internal and external Safety System audits • Assist in developing SOPs for the safety system and its maintenance

🎯 Requirements

• Master’s degree in Computer Science, Engineering, or a related quantitative discipline, and 5 years of relevant experience, OR bachelor’s degree in the same fields and 7 years of progressively responsible experience • Foreign degree equivalent accepted • Pharmacovigilance systems experience, including Argus Safety or another Drug Safety Database • Ability to write advanced SQL queries and develop reports using BI reporting tools • Experience with aggregate safety reports and inspection-related requests • Knowledge of SDLC processes and regulatory requirements related to GxP system implementations • Any suitable combination of education, training, and/or experience is acceptable

🏖️ Benefits

• Telecommuting option • Annual bonus plan eligibility for non-commercial roles • Opportunity to own BeOne Medicines Ltd. stock through discretionary equity awards • Voluntary participation in the Employee Stock Purchase Plan • Medical insurance • Dental insurance • Vision insurance • 401(k) • FSA/HSA • Life insurance • Paid time off • Wellness benefits