PAREXEL has supported the Bio-Tech and Pharmaceutical industries in helping the development of new drugs and treatments on a global basis. As a leading global biopharmaceutical service provider, they supply knowledge-based contract research, medical communications and consulting services across a broad range of therapeutic areas to the worldwide pharmaceutical, biotechnology and medical device industries.
Post : Drug Safety Associate I
Job Description
The Drug Safety Associate will provide technical and process-related support to drug safety management (clinical trial and post-marketed) and medical monitoring activities, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs).
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
Candidate Profile
• Related experience gained in a healthcare environment is an advantage
• 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
• 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.
Additional Information
Qualification : Degree in Pharmacy, Nursing, Life Science
Experience : 2 years
Location : SAS Nagar (Mohali), India
Functional Area : Medical Sciences
End Date : 30th November 2024
See All B.Pharm Alerts M.Pharm Alerts M.Sc Alerts Hyderabad Alerts
See All Other Jobs in our Database
Subscribe to Pharmatutor Job Alerts by Email
.png)
