Location: SAS Nagar (Mohali), India
PAREXEL, a leader in the biopharmaceutical service industry, is seeking a Drug Safety Associate I to join our team. As a key player in supporting the development of new drugs and treatments, you will contribute to our mission of advancing healthcare globally.
Job Description
The Drug Safety Associate will provide essential technical and process support to drug safety management for both clinical trials and post-marketed products. Your role will ensure compliance with relevant regulations and Standard Operating Procedures (SOPs).
Key Responsibilities:
- Design, develop, and maintain Power BI reports and dashboards, leveraging data from Veeva Vault RIM.
- Collaborate with business users, analysts, data engineers, and stakeholders to gather requirements and translate them into technical solutions.
- Analyze complex business and operational system requirements; recommend solution options.
- Integrate data from various sources into Power BI using SQL queries, SharePoint, and Dataflows.
- Write and optimize SQL queries for data extraction and manipulation for reporting.
- Participate in meetings to understand business needs and provide technical insights.
- Stay updated on the latest developments in Power BI, SQL, and Power Platform.
- Propose and implement improvements to existing reports and processes.
- Support production environments and assist users with data and reporting issues.
- Manage regulatory information for medicinal products, including data entry in Veeva Vault.
- Ensure compliance with global regulatory reporting obligations for adverse event reporting.
- Assist in developing project-specific safety procedures, workflows, and templates.
- Conduct data entry of case reports into safety databases and manage queries.
- Support Medical Directors/Safety Physicians in medical monitoring activities as needed.
- Participate in client and investigator meetings, audits, and training sessions.
- Track and file submission cases, assist with unblinding of SUSARs, and measure investigative site performance.
Candidate Profile:
- Degree in Pharmacy, Nursing, Life Science, or a related health field (or equivalent experience).
- Minimum 2 years of experience with the entire Power BI stack.
- Proficient in Power BI, including Power Query, DAX, and Power BI Service.
- Strong understanding of Veeva Vault RIM and data visualization best practices.
- Excellent analytical, problem-solving, and communication skills.
- Ability to manage multiple tasks with attention to detail and flexibility in work assignments.
Additional Information:
- Qualification: Degree in Pharmacy, Nursing, Life Science
- Experience: Minimum 2 years in a relevant role
- Functional Area: Medical Sciences
- Application Deadline: 30th November 2024