Clinical Research Associates - Data Management / Pharmacovigilance / Regulatory Affairs

Why This Role Matters
These roles play an important role in supporting clinical research operations, drug safety monitoring, regulatory compliance, and clinical data management. Professionals in these positions contribute to maintaining high standards of patient safety, regulatory accuracy, and data integrity across pharmaceutical and clinical research projects.

Job Description
Bioclinaarc is currently recruiting life science professionals for multiple positions including Data Manager, Pharmacovigilance / Drug Safety Associate, and Regulatory Affairs Associate. These roles involve managing clinical trial data, monitoring drug safety reports, and supporting regulatory submissions to ensure compliance with international regulatory standards.

Key Features of the Role
Opportunity to work in clinical research, drug safety, and regulatory affairs
Exposure to global standards including ICH-GCP and regulatory compliance frameworks
Involvement in clinical data management and pharmacovigilance operations
Collaboration with clinical research, regulatory, and biostatistics teams
Career growth opportunities in pharmaceutical and clinical research industries

Available Positions & Vacancies

Position – Vacancies
Data Manager – 1
Pharmacovigilance / Drug Safety Associate – 1
Regulatory Affairs Associate – 2

Responsibilities

Data Manager
Manage and maintain clinical trial datasets and databases
Perform data validation, query management, and data cleaning
Ensure compliance with ICH-GCP, CDISC standards, and regulatory guidelines
Coordinate with clinical research teams and biostatistics teams

Pharmacovigilance / Drug Safety Associate
Process adverse event (AE) and serious adverse event (SAE) reports
Perform MedDRA coding and case narrative preparation
Conduct case triage, literature screening, and signal detection
Maintain compliance with global pharmacovigilance regulations

Regulatory Affairs Associate
Prepare and review regulatory submissions and dossiers
Maintain regulatory documentation and compliance records
Support regulatory strategy and product lifecycle management
Coordinate with regulatory agencies and internal teams

Required Qualifications

Educational Requirements
B.Pharm / M.Pharm
MSc in Life Sciences or related disciplines

Experience and Skills
Knowledge of clinical research processes and regulatory compliance
Understanding of pharmacovigilance and drug safety reporting systems
Familiarity with clinical data management practices and standards
Good analytical, documentation, and communication skills
Ability to work collaboratively in cross-functional teams

Salary Insights

Data Manager – ₹5 – ₹9 LPA
Pharmacovigilance Associate – ₹4 – ₹8 LPA
Regulatory Affairs Associate – ₹4 – ₹9 LPA

Company Overview
Bioclinaarc is a clinical research and pharmaceutical services organization supporting global drug development activities. The company works across domains such as pharmacovigilance, regulatory affairs, clinical data management, and biostatistics to support safe and effective pharmaceutical research.

FAQs

What qualifications are required for these roles?
Candidates should have B.Pharm, M.Pharm, or MSc in Life Sciences or related fields.

Which roles are currently open?
The company is hiring for Data Manager, Pharmacovigilance / Drug Safety Associate, and Regulatory Affairs Associate.

What is the expected salary range?
The estimated salary ranges from ₹4 LPA to ₹9 LPA depending on the role and experience.

What type of work will candidates perform?
The roles involve clinical data management, drug safety monitoring, and regulatory documentation activities.

Application Tips
Highlight experience or internships in clinical research, pharmacovigilance, or regulatory affairs
Mention familiarity with tools like MedDRA, CDISC, or clinical databases
Showcase strong documentation and analytical skills
Include knowledge of ICH-GCP and global regulatory guidelines
Emphasize teamwork and communication skills in clinical research environments