Associate Director, Safety Reporting

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

📋 Description

• Provide support and oversee the functionality, maintenance, and validation of data and analytics solutions, which encompass business intelligence and automation.

• Manage modifications to data and analytics solutions in accordance with the change control policy, including configuration alterations and system upgrades.

• Oversee the development and validation of aggregate safety reports.

• Participate in the specification, development, validation, and implementation of ad hoc reports.

• Maintain necessary validation documentation.

• Ensure the timely distribution of business intelligence information to users.

• Train departmental personnel on reporting solutions and Safety Systems.

• Communicate project statuses and collaborate on resolving issues.

• Provide leadership and technical expertise as a member of the team.

• Act in a consultative capacity to address safety system issues and interface with other pharmacovigilance tools.

• Engage in the implementation of Safety informatics systems, including Safety Data Mart, signal detection and surveillance tools, and reporting systems.

• Assist in both internal and external audits of the Safety System.

• Support the development of Standard Operating Procedures (SOPs) for the safety system and its upkeep.

⛳️ Requirements

• A Master’s degree in Computer Science, Engineering, or a related quantitative field, accompanied by 5 years of relevant experience, OR a Bachelor’s degree in the same areas with 7 years of progressively responsible experience.

• Acceptance of foreign degree equivalents is available.

• Experience with pharmacovigilance systems, including Argus Safety or another Drug Safety Database.

• Proficiency in writing advanced SQL queries and developing reports using BI reporting tools.

• Familiarity with aggregate safety reports and inspection-related requests.

• Understanding of Software Development Life Cycle (SDLC) processes and regulatory requirements associated with GxP system implementations.

• Any appropriate combination of education, training, and/or experience is acceptable.

🏝️ Benefits

• Option for telecommuting.

• Eligibility for an annual bonus plan for non-commercial roles.

• Opportunity to acquire BeOne Medicines Ltd. stock through discretionary equity awards.

• Voluntary participation in the Employee Stock Purchase Plan.

• Medical insurance coverage.

• Dental insurance coverage.

• Vision insurance coverage.

• 401(k) retirement plan.

• Flexible Spending Account (FSA) / Health Savings Account (HSA).

• Life insurance coverage.

• Paid time off.

• Wellness benefits.