Job ID 2025-9103
Reporting & Analytics Consultant / Drug Safety / PV
Global Safety Systems
Cambridge, MA (Hybrid, preference is 2 days onsite)
8 month contract with perm potential
Pay Rate: $90 - $90.00 per hour
***Minimum of 4 years' experience in drug safety is required along with reporting solutions and used in context of PV.
***Argus experience is required
***NICE TO HAVE: Experience with PV Reports (huge plus)
EDUCATION: BS - Open to other degrees with necessary experience (PharmD that transitioned to data analytics)
Summary: Consultant, Reporting and Analytics Global Safety Systems (GSS) will work with different stakeholders to generate the data and listings using reporting tools like OBIEE, BIP, and visualizations. In addition, the role supports analyzing the need for new reporting and developing and validating the same.
Qualifications:
- BS Computer Science/equivalent qualification with at least 4 years of experience.
- Experience in Oracle Argus Safety is required. Additionally, work experience with Oracle Cloud is preferred.
- Experience in reporting tools (OBIEE, Cognos, Business Objects, BIP) is required. Knowledge of OBIEE/BIP is preferred.
- Relational database knowledge working with Oracle and SQL is required.
- General knowledge of the Software Development Lifecycle (SDLC) is required, and experience performing qualification/validation is required.
- Knowledge of PSUR/PBRER/DSUR is preferred.
- Experience authoring various Validation deliverables.
- Experience executing test scripts (OQs/PQs)
Summary of Key Responsibilities:
- Work with GPSRM staff to create solutions for extracting and analyzing safety data. Experience in BI Publisher, Argus Analytics (OBIEE) is preferred.
- Responsible for generating formal reports, summaries, and listings supporting medical monitoring, signal detection, and aggregate reporting deliverables (PBRER, DSUR) in conjunction with the database service provider.
- Work with GPSRM staff to complete the data request forms and coordinate with the database service provider to complete requests.
- Perform quality checks on data requests generated by the database service provider; Identify discrepancies between the request and the implementation and resolve or initiate their resolution.
- Assist in the process of qualification/validation of GSD applications.
- Willing to take on additional departmental tasks, as assigned to ensure Acompliance with all regulatory agency and ICH regulations and guidelines governing the reporting of adverse events and product complaints.
Estimated Min Rate: $90.00
Estimated Max Rate: $95.00
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.
Visit
https://www.yoh.com/applicants-with-disabilities
to contact us if you are an individual with a disability and require accommodation in the application process.
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.
YOH Services LLC
Mar 31, 2025