Drug Safety Specialist

When our values align, there's no limit to what we can achieve.   At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Job Description

•    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 backround and expeience 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