Parexel Pharmacovigilance Job Vacancies
Parexel, a leader in global clinical research and healthcare, is currently hiring for the role of Drug Safety Associate I in their SAS Nagar (Mohali), India office. This position offers a promising opportunity for those in the medical sciences field to gain hands-on experience in pharmacovigilance, supporting clinical trials and post-marketing safety initiatives. Candidates will contribute to safety data collection, compliance, and reporting – essential elements in safeguarding public health.Drug Safety Associate | Job Overview
As a Drug Safety Associate I at Parexel, you will play a vital role in drug safety management, ensuring compliance with regulatory requirements and contributing to global medical safety. The role requires a background in medical sciences, strong analytical skills, and knowledge of pharmacovigilance operations. Location: SAS Nagar (Mohali), India Department: Medical Sciences Experience Required: 1-3 years in a relevant field Education: Degree in Pharmacy, Nursing, Life Sciences, or related disciplinesResponsibilities
As a Drug Safety Associate I, your key responsibilities include:- 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
Parexel Pharmacovigilance Vacancies | Drug Safety Associate I[/caption]
Key Skills and Competencies
- Pharmacovigilance Knowledge: Experience with pharmacovigilance databases and systems like Veeva Vault and NuGenesis
- Technical Skills: Proficiency in Power BI for data visualization and SQL for database management
- 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.
Work Schedule
This role requires working US Eastern Standard Time hours to collaborate effectively with global teams. Flexibility and adaptability in managing time zones are essential.Education and Experience Requirements
- Degree Requirements: Bachelor’s in Pharmacy, Nursing, Life Sciences, or related field
- Experience: 1-3 years of experience in pharmacovigilance, drug safety, or a related healthcare role
How to Apply: To join Parexel as a Drug Safety Associate I, submit your application on their official job portal.
