Pharmacovigilance Reporting Analyst

We're Hiring: Pharmacovigilance Reporting Analyst - Make an Impact with Advantage xPO! Join a team of professionals in Cambridge, MA.

Hybrid Schedule | 2 days per week in Cambridge, MA

Work Hours | Monday - Friday (9 AM - 5 PM)

Pay | $90 - $97 per hour

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)

Pharmacovigilance Reporting Analyst Job Description

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.

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 by your immediate supervisor, to ensure Alnylam's compliance with all regulatory agency and ICH regulations and guidelines governing the reporting of adverse events and product complaints.

Employee Benefits

Medical, dental, vision, and pet insurance | 401(k) Retirement Savings Plans | Employee Assistance Program (EAP) | Commuter/Parking Accounts | People Perks | Health Savings Account (HSA) | AD & D Insurance

How to Apply

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With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit AdvantageTechnical.com.

Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact your local branch. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.