Drug Safety Associate I

Parexel

2+ years

Not Disclosed

Mohali

10 Oct. 30, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

The Drug Safety Associate will provide essential technical and process-related support for drug safety management, both for clinical trials and post-marketed products. This role ensures compliance with relevant regulations and Standard Operating Procedures (SOPs).

Key Accountabilities:

Power BI Development: Design, develop, and maintain Power BI reports and dashboards, utilizing data extracts from Veeva Vault RIM for enterprise-wide users.
Collaboration: Work closely with business users, analysts, data engineers, and stakeholders to gather requirements and translate them into technical solutions.
System Analysis: Analyze complex business and operational requirements, recommending suitable solution options.
Data Integration: Integrate data from various sources into Power BI using SQL queries, SharePoint, and Dataflows to provide comprehensive insights.
SQL Proficiency: Write and optimize SQL queries for data extraction and manipulation for reporting purposes.
Stakeholder Engagement: Participate in meetings to understand business needs and provide technical insights.
Continuous Learning: Stay updated with the latest developments and best practices in Power BI, SQL, and Power Platform.
Process Improvement: Propose and implement enhancements to existing reports, dashboards, and processes.
Production Support: Assist business users with any data and reporting issues in the production environment.
Regulatory Management: Manage regulatory information for Medicinal Products, Vaccines, Devices, and Nutraceuticals, including data entry in Veeva Vault.
Regulatory Compliance: Ensure compliance with global regulatory reporting obligations and internal timelines for adverse event reporting.
Project Support: Assist in the development of project-specific safety procedures, workflows, and templates.
Database Management: Aid in safety database setup, data entry guidelines development, and user acceptance testing.
Case Management: Enter case reports into safety databases, manage queries, and perform follow-ups.
Support Roles: Assist Drug Safety Specialists and Safety Service Project Leaders with additional activities as required.
Communication: Inform management of potential project changes and support Medical Directors/Safety Physicians in medical monitoring activities.
Training Participation: Attend internal drug safety and project-specific training sessions.
Audit Preparation: Prepare for and participate in audits and inspections.
Delegation: Delegate tasks appropriately to Drug Safety Assistants.
Reporting Procedures: Assist in developing expedited reporting procedures and registration with authorities for electronic reporting.
Submissions: Manage submission of safety reports to investigators via the International Safety Information System (ISIS).

Skills:

Regulatory Information Management: Background in managing regulatory information for Medicinal Products, including data entry in Veeva Vault.
Global Reporting Awareness: Knowledge of global regulatory reporting obligations.
Power BI Expertise: Minimum of 2 years’ experience with the entire Power BI stack.
Technical Proficiency: Strong understanding of Veeva Vault RIM, with at least 2 years of experience.
Data Visualization: Knowledge of best practices in data visualization.
Analytical Skills: Excellent analytical and problem-solving abilities.
Communication Skills: Strong interpersonal, verbal, and written communication skills.
Flexibility: A flexible attitude towards work assignments and a willingness to learn.
Task Management: Ability to manage multiple tasks with enthusiasm and attention to detail.

Knowledge and Experience:

Experience in a healthcare environment is advantageous.

Education:

Degree in Pharmacy, Nursing, Life Science, or a related health field, or equivalent work experience. Associates degree in any of the above with appropriate work experience is also acceptable.

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Drug Safety Associate I

Job Description

Key Accountabilities:

Skills:

Knowledge and Experience:

Education:

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