Pharmacovigilance Reporting & Analytics Consultant

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

Key Responsibilities

• 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.

Must-Have Requirements

• 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.

Nice-to-Have Skills

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

Estimated Min Rate: $60.20
Estimated Max Rate: $86.00

What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you.

Benefit eligibility is in accordance with applicable laws and client requirements. 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. All qualified applicants are welcome to apply.

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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