Parexel Hiring Patient Safety Specialist | Pharmacovigilance

Parexel Hiring Patient Safety Specialist | Pharmacovigilance Jobs in Hyderabad for Life Sciences Professionals

Parexel is hiring for Patient Safety Specialist roles in its Medical Sciences and Pharmacovigilance division based in Hyderabad, India. This is a full-time opportunity for candidates with experience in drug safety, ICSR processing, and regulatory reporting. While the exact number of vacancies is not disclosed, multiple openings are expected within global pharmacovigilance teams, making it a strong career move for professionals aiming to grow in drug safety and regulatory affairs.

This role offers direct exposure to global safety reporting systems, clinical safety data management, and regulatory compliance across multiple regions.

Company Overview

Parexel is a leading global clinical research organization (CRO) that supports pharmaceutical, biotechnology, and medical device companies in developing and delivering life-changing therapies. With decades of experience in clinical trials, regulatory consulting, and pharmacovigilance services, Parexel plays a critical role in ensuring patient safety and compliance across the drug development lifecycle.

The company works closely with global regulatory authorities such as the FDA, EMA, and other health agencies, helping bring safe and effective treatments to market. Parexel is known for its strong focus on quality, compliance, and innovation in clinical research and drug safety operations.

Job Role & Responsibilities

As a Patient Safety Specialist, you will be responsible for managing pharmacovigilance activities including case processing, regulatory submissions, and safety data analysis.

ICSR Processing & Case Management

• Process Individual Case Safety Reports (ICSRs) as per SOPs and regulatory timelines
• Perform case assessment, narrative writing, and quality checks
• Maintain safety databases and ensure data accuracy
• Support compliance metrics tracking and reporting

Safety Submissions & Regulatory Compliance

• Execute safety report submissions to global regulatory authorities
• Support periodic reports and aggregate safety reporting
• Maintain compliance with ICH guidelines and global PV regulations
• Assist in audit and inspection readiness

Literature Review & Signal Detection

• Conduct literature searches for adverse drug reactions and safety signals
• Screen publications and support medical review processes
• Perform quality checks and maintain compliance with global standards

Affiliate & Regulatory Support

• Coordinate safety information exchange between global and local teams
• Support regulatory intelligence activities and country-specific requirements
• Assist in product registration, database maintenance, and reporting rules

Quality & Process Improvement

• Participate in quality assurance activities and process optimization
• Support training, mentoring, and cross-functional collaboration
• Identify risks and implement corrective actions

This role is critical in ensuring patient safety, regulatory compliance, and high-quality pharmacovigilance operations in global clinical research programs.

Eligibility / Qualifications

Candidates must meet the following criteria:

• Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related field

Relevant courses include: B.Pharmacy, M.Pharmacy, Pharm.D, BSc Life Sciences, MSc Pharmacology, MSc Clinical Research, MBBS

Key skills required:

• Strong understanding of pharmacovigilance and drug safety processes
• Experience in ICSR processing and regulatory reporting
• Knowledge of ICH guidelines, FDA, and EMA regulations
• Familiarity with safety databases and reporting systems
• Analytical thinking and attention to detail
• Effective communication and teamwork skills

Location & Salary

• Location: Hyderabad, India
• Salary: Approximately ₹5 LPA – ₹12 LPA (based on pharmacovigilance roles in India)

Application Process

Interested candidates can apply through the official Parexel careers portal:

Apply Here: https://jobs.parexel.com/en/job/-/-/877/94322228640

Ensure your resume highlights your pharmacovigilance experience, ICSR handling, and regulatory knowledge to improve your chances of selection.

Frequently Asked Questions (FAQs)

1. What is the main role of a Patient Safety Specialist?
The role focuses on pharmacovigilance activities such as ICSR processing, safety reporting, and regulatory compliance.

2. What qualifications are required?
Candidates must have a degree in Life Sciences, Pharmacy, or related fields.

3. Is prior experience mandatory?
Yes, experience in drug safety or pharmacovigilance is preferred.

4. What systems will I work on?
You will work with safety databases and regulatory reporting systems.

5. Where is the job located?
The role is based in Hyderabad.

Summary Table

Company	Parexel
Vacancies	Patient Safety Specialist
Required Education	B.Pharmacy, M.Pharmacy, Pharm.D, BSc Life Sciences, MSc Clinical Research, MBBS
Experience	Pharmacovigilance / Drug Safety Experience