Opportunity to work as Drug Safety Specialist at PAREXEL – Apply before 28th February 2025

Company: PAREXEL
Location: Mohali
Category: Medical Sciences
Experience Required: 4 Years
Application Deadline: 28th February 2025

About PAREXEL

PAREXEL is a globally recognized biopharmaceutical service provider, supporting the biotechnology, pharmaceutical, and medical device industries in the development of new treatments. The company offers contract research, medical communications, and consulting services across various therapeutic areas.

Position Overview

As a Drug Safety Specialist, you will play a key role in ensuring the safety and compliance of pharmaceutical products. This role involves managing clinical trial and post-marketing drug safety activities, monitoring adverse event reports, and ensuring adherence to regulatory standards.

Key Responsibilities

1. General Responsibilities

• Maintain knowledge of adverse event safety profiles, client guidelines, and regulatory requirements.
• Ensure compliance with global drug safety regulations and internal SOPs.
• Assist in developing project-specific safety workflows and templates.
• Provide training to internal teams on drug safety and project-specific processes.
• Participate in audits and inspections.
• Collaborate with stakeholders to ensure high-quality safety reporting.
• Mentor new team members and support overall team development.

2. Case Processing

• Monitor incoming safety reports from various sources.
• Assess reports for completeness, accuracy, and regulatory compliance.
• Enter case data into safety databases and ensure proper MedDRA coding.
• Perform quality control checks on safety data and documentation.
• Conduct literature searches and enter relevant cases into safety databases.
• Support compliance activities, including late case investigations.

3. Drug Safety Reporting

• Perform quality control of case reports, line listings, and regulatory submissions.
• Develop expedited reporting procedures.
• Ensure timely reporting to regulatory authorities and investigators.
• Track submission cases and maintain compliance records.
• Manage unblinding of SUSARs, as required.

4. Literature Search and Review

• Develop and implement literature search strategies for safety assessments.
• Retrieve and analyze scientific articles for relevant safety data.
• Perform quality checks on literature search results.
• Maintain an updated database of scientific literature sources.

Candidate Profile

Qualifications

• Degree in Life Sciences, Health, or Biomedical Sciences (Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.).
• Advanced degrees (e.g., Medicine, Dentistry, Nursing) with clinical exposure are advantageous.

Experience

• Minimum of 4 years of experience in drug safety or pharmacovigilance.

Skills & Competencies

• Strong understanding of drug safety processes and global regulations.
• Experience in safety data analysis and evaluation.
• Excellent verbal and written communication skills.
• Ability to work effectively in a team-oriented environment.
• Strong analytical and problem-solving skills.
• Proficiency in MS Office and web-based applications.
• Ability to manage multiple tasks efficiently and meet regulatory deadlines.

How to Apply

Interested candidates can apply by submitting their resume before 28th February 2025.

Join PAREXEL and contribute to the advancement of global healthcare through innovative drug safety solutions!