Consultant Reporting and Analytics, Global Safety Systems - Hybrid, Cambridge, MA

In this hybrid role based in Cambridge, MA, you will partner with Safety and Risk Management teams to develop, test, and validate cutting-edge reporting solutions. Your work will support critical safety activities, including medical monitoring, signal detection, and regulatory reporting, ensuring compliance and enhancing safety processes across the organization.

• Collaborate with safety stakeholders to create and refine safety data reports, visualizations, and listings using pharmacovigilance tools like PV Reports, Oracle Analytics Server, OBIEE, BI Publisher, or Cognos. Experience with PV Reports is preferred.
• Generate and deliver formal safety reports, summaries, and listings to support regulatory and monitoring needs, including PBRERs and DSURs.
• Document reporting requirements, complete data request forms, and coordinate with external database service providers to ensure timely and accurate outputs.
• Perform quality checks on outputs from service providers, identify discrepancies, and work with teams to resolve issues promptly.
• Support system monitoring activities, including overseeing ETL processes and scheduled report execution, to maintain reliable reporting workflows.
• Assist in the qualification and validation of safety systems and reporting solutions, including report validation activities, to meet compliance standards.
• Contribute to ongoing departmental responsibilities related to regulatory adherence and ICH guidelines for adverse event and product complaint reporting.

• Experience with pharmacovigilance reporting tools such as PV Reports, Oracle Analytics Server, OBIEE, BI Publisher, or Cognos (PV Reports experience preferred).
• Strong ability to generate reports, analyze safety data, and support safety monitoring activities.
• Ability to document requirements, complete data requests, and coordinate with external partners.
• Knowledge of validation, quality checks, and system monitoring activities related to safety reporting.

• Experience with PV Reports.
• Knowledge of regulatory standards related to safety reporting and compliance.

Estimated Min Rate: $60.20

Estimated Max Rate: $86.00

Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• Met Life Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note:

Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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