Parexel Pharmacovigilance Jobs: Drug Safety Specialist in Mohali

Parexel Pharmacovigilance Jobs – Drug Safety Specialist | Mohali: Join a Global Leader in Clinical Research

Parexel, a leading global clinical research organization (CRO), is hiring a Drug Safety Specialist for its Mohali location. If you have a degree in Pharmacy, Nursing, Life Sciences, or a related field, along with 2+ years of experience in pharmacovigilance, this is your opportunity to contribute to groundbreaking drug safety and regulatory compliance projects. Join Parexel and be part of a team dedicated to improving patient outcomes worldwide.

About Parexel
Parexel is a trusted name in the clinical research industry, known for its commitment to innovation, quality, and patient safety. With a presence in over 50 countries, Parexel provides comprehensive clinical development services to pharmaceutical, biotechnology, and medical device companies.

Job Overview

• Position: Drug Safety Specialist
• Location: Mohali, India
• Job ID: R0000031160
• Category: Medical Sciences
• Qualifications: Degree in Pharmacy, Nursing, Life Sciences, or related field
• Experience: 2+ years in pharmacovigilance or related roles

Key Responsibilities
As a Drug Safety Specialist at Parexel, you will:

• 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

Qualifications and Skills
To excel in this role, you should have:

• Education: Degree in Pharmacy, Nursing, Life Sciences, or a related field.
• Experience:
  • 2+ years of experience in pharmacovigilance or drug safety.
  • Proficiency in Power BI, Power Query, DAX, and Power BI Service.
  • Strong understanding of Veeva Vault RIM.
• Technical Skills:
  • Strong data visualization and analytical skills.
  • Proficiency in SQL queries and data integration.

How to Apply
If you meet the qualifications and are passionate about drug safety and pharmacovigilance, apply now for the Drug Safety Specialist position at Parexel. Click here to apply: Apply Now.

Tagged as: Good Clinical Practice (GCP), Pharmaceutical Careers