Parexel Pvt Ltd Hiring for Drug Safety Associate I

Key Accountabilities:

• Responsible for design, develop, and maintain Power BI reports and dashboards without/with Data extract from Veeva Vault RIM for enterprise-wide users.
• Work closely with business users, business analysts, data engineers, and stakeholders to gather requirements and translate them into technical solutions.
• Analyze complex business and operational system requirements and recommend solution options.
• Integrate data from various sources into Power BI using SQL queries, SharePoint, and Dataflows to provide comprehensive insights.
• Write and optimize SQL queries to extract and manipulate data for reporting purposes.
• Participate in meetings and discussions to understand business needs and provide technical insights.
• Stay updated with the latest developments and best practices in Power BI, SQL, and Power Platform.
• Propose and implement improvements to existing reports, dashboards, and processes.
• Responsible to support the production environment to assist the business users for any issues related to data and reporting.
• Experienced in the management of the regulatory information of Medicinal Products/Vaccines/Devices/Nutraceuticals which includes performing the data entry in the Veeva Vault.
• Awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
• Assist in development of project specific safety procedures, workflows and template
• Assist in project specific safety database setup, development of data entry guidelines, and user acceptance testing
• Data entry of case reports into safety database / tracking system
• Request follow-up and perform query management
• Assist with additional Drug Safety Specialist and/or Safety Service Project Leader (SSPL) activities as required
• Inform Line Manager (LM)/Team Manager, Safety Services Project Leader (SSPL) or Project Leader (PL) and Regional Head of PV Operations of potential change-in-scope of projects
• Support of Medical Directors/Safety Physicians, as needed, in medical monitoring activities
• Participate in client and investigator meetings as required
• Attend internal, drug safety and project specific training sessions
• Perform literature searches
• Preparation for, participation in, and follow up on audits and inspections
• Delegate work as appropriate to Drug Safety Assistants
• Assistance in development of Expedited Reporting Procedures
• Assistance with registration with relevant authorities for electronic reporting on behalf of sponsor
• Assistance with setting up and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy)
• Submission of safety reports to investigators via ISIS (International Safety Information System)
• Assist with measuring investigative site performance in conducting required tasks in ISIS
• Tracking and filing of submission cases as required
• Assist with unblinding of SUSARs, as required
• Support collection and review of metrics for measuring reporting compliance

Skills:

The background and experience in management of regulatory information of Medicinal Products/Vaccines/Devices/Nutraceuticals which includes performing the data entry in the Veeva Vault.

Awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting

A minimum of 2 years’ experience with the entire Power BI stack is required.

Proficiency in Power BI, including Power Query, DAX, and Power BI Service.

Strong understanding of Veeva Vault RIM with minimum experience of 2 years.

Strong understanding of data visualization best practices.

Excellent analytical and problem-solving skills.

Excellent interpersonal, verbal and written communication skills.

A flexible attitude with respect to work assignments and new learning.

Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.

Willingness to work in a matrix environment.

Knowledge and Experience:

• Related experience gained in a healthcare environment is an advantage

Education:

• Degree in Pharmacy, Nursing, Life Science or other health-related field, or equivalent qualification/work experience
• Associates degree in any of the above with appropriate work experience