Parexel is a leading global biopharmaceutical services company that focuses on clinical trials and regulatory consulting to accelerate drug development. With a strong commitment to innovation and patient-centric solutions, Parexel provides end-to-end clinical research, regulatory, and market access solutions to improve global healthcare. The company operates in multiple locations worldwide, including India, where it continues to expand its expert team in clinical research and pharmacovigilance.

Job Openings at Parexel

Parexel is currently hiring for two key positions:

1. Clinical Data Analyst I – Locations: Bengaluru, Hyderabad
2. Drug Safety Specialist – Location: Mohali

1. Clinical Data Analyst I

Responsibilities:

• Conduct data validation and cleaning activities, including query management and manual/SAS listing reviews.
• Manage data processing tasks, from database setup to database lock.
• Prepare and maintain Data Management Documents (Trial Master File) as per industry guidelines.
• Lead/perform User Acceptance Testing (UAT) for clinical database setups.
• Review protocols and Electronic Data Capture (EDC) Entry Screens.
• Track and review Case Report Forms (CRFs) and support data entry.
• Ensure compliance with Standard Operating Procedures (SOPs) and ICH/GCP Guidelines.
• Conduct Quality Control (QC) activities on databases and patient data.
• Maintain training compliance as per job roles and assist in training new team members.

Qualifications:

• Bachelor’s degree in life sciences, pharmacy, or a related medical field.
• Basic knowledge of data management processes and data validation flow.
• Understanding of relevant ICH-GCP guidelines and regulatory requirements.
• Exposure to Clinical Data Management Systems (e.g., InForm, Rave, Veeva, Datalabs, ClinBase).
• Experience in clinical research and data management.
• Familiarity with medical terminology and coding dictionaries like MedDRA & WHODRUG.

Skills Required:

• Strong analytical and problem-solving skills.
• Commitment to quality and accuracy.
• Good time management and prioritization abilities.
• Effective teamwork and collaboration skills.
• Proficiency in Microsoft Office and basic IT skills.
• Fluency in English (written and spoken).

2. Drug Safety Specialist

Responsibilities:

• Process Individual Case Safety Reports (ICSRs) from various sources.
• Conduct literature searches, signal detection, and regulatory tracking.
• Ensure compliance with global pharmacovigilance regulations.
• Review adverse event reports and maintain accurate documentation.
• Assist in project-specific safety procedures and workflow development.
• Participate in audits, inspections, and compliance monitoring.
• Coordinate safety reporting, including regulatory submissions and database management.
• Conduct quality control of case reports and regulatory submissions.
• Perform drug safety training and mentoring for new recruits.

Qualifications:

• Bachelor’s degree in Life Sciences, Pharmacy, Microbiology, Biochemistry, Biotechnology, or related fields.
• 4+ years of experience in drug safety/pharmacovigilance (preferred).
• Strong knowledge of medical terminology.
• Understanding of global safety regulations and drug development processes.

Skills Required:

• Proficiency in database and literature searches.
• Excellent analytical, problem-solving, and organizational skills.
• Strong verbal and written communication skills.
• Ability to handle multiple tasks efficiently.
• Knowledge of regulatory submission processes.
• Familiarity with pharmacovigilance tools and reporting systems.

Application Link for Clinical data Analyst

Application Link for Drug Safety Specialist

AD