Drug Safety Associate I

SAS Nagar (Mohali), India

**Job ID** R0000028775

**Category** Medical Sciences

**ABOUT THIS ROLE**:
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

**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