Parexel hiring Patient Safety Associate I in Hyderabad for pharmacovigilance, ICSR processing, literature review, and global safety reporting roles.
Company Overview
Parexel is a globally respected clinical research organization that supports pharmaceutical, biotechnology, and medical device companies across the full product lifecycle. From early clinical development to post-marketing safety and regulatory services, Parexel plays a vital role in advancing therapies that improve patient outcomes worldwide. The organization is known for its strong ethical foundation, robust compliance culture, and commitment to developing skilled professionals in clinical research and pharmacovigilance. Parexel hiring Patient Safety Associate I
Parexel India continues to expand its safety operations and is currently hiring Patient Safety Associate I professionals to support global drug safety and regulatory reporting activities.
Job Location & Employment Type
- Location: Hyderabad, Telangana, India
- Employment Type: Full-time
- Function: Pharmacovigilance / Patient Safety
- Work Model: Office-based
Open Positions / Department Details
This opening is for the Patient Safety Associate I role within Parexel’s Global Safety Operations team. The position is entry-level and ideal for candidates looking to build a long-term career in pharmacovigilance, clinical safety, and regulatory reporting. Parexel hiring Patient Safety Associate I
The role provides structured exposure to Individual Case Safety Report (ICSR) processing, safety submissions, literature surveillance, affiliate coordination, and regulatory intelligence under guided supervision. Parexel hiring Patient Safety Associate I
Key Roles & Responsibilities
General Safety Operations
- Build foundational knowledge of drug safety profiles, labeling requirements, and global regulatory frameworks
- Follow project-specific workflows, internal SOPs, and client-defined procedures
- Support compliance with regulatory timelines and internal quality standards
- Assist in audit and inspection readiness activities as assigned
- Track and review basic operational metrics under supervision
- Ensure accurate documentation, archiving, and timely completion of timesheets
- Participate in internal and client-mandated training programs through LMS
ICSR Processing & Case Management
- Monitor incoming safety reports from multiple sources including safety mailboxes, EudraVigilance, and literature searches
- Perform triage of incoming cases to assess validity, completeness, and legibility
- Conduct literature searches and identify valid safety cases
- Enter case data into safety databases in accordance with client conventions
- Prepare ADR forms and coversheets where applicable
- Perform MedDRA coding following official term selection guidelines
- Ensure correct assessment of seriousness, expectedness, and causality
- Draft medically coherent case narratives based on reported data
- Manage follow-ups, queries, and translation requests
- Perform quality and validation checks on processed cases
Parexel hiring Patient Safety Associate I
Safety Submissions & Compliance
- Support submission of ICSRs and periodic safety reports to health authorities, ethics committees, and investigators
- Maintain awareness of global safety submission requirements
- Assist with electronic reporting registrations and gateway submissions
- Support setup of country-specific reporting schedules
- Track compliance metrics and support reconciliation activities
- Assist in preparation of documents for EDMS and eTMF systems
- Contribute to inspection readiness and regulatory audits
Literature Search & Review
- Develop and maintain literature search strategies based on client requirements
- Screen medical and scientific literature for potential safety signals
- Review abstracts and full-text articles for adverse drug reactions
- Support peer review of literature screening outcomes
- Maintain local journal lists and perform periodic strategy updates
- Identify and escalate potential safety concerns for medical review
Affiliate & Regulatory Support
- Coordinate safety data exchange with local affiliates
- Support country-specific literature monitoring and follow-ups
- Assist with regulatory databases, product registrations, and lifecycle updates
- Support global regulatory submissions including renewals and variations
- Maintain regulatory intelligence trackers and safety requirement databases
- Collaborate with global safety intelligence teams to stay aligned with current regulations
Parexel hiring Patient Safety Associate I
Eligibility Criteria
Education
- Degree in Life Sciences, Pharmacy, Biomedical Sciences, or related disciplines
(B.Pharm, M.Pharm, BSc, MSc – Microbiology, Biotechnology, Biochemistry, etc.)
Experience
- Entry-level role
- Prior exposure to healthcare, clinical research, or pharmacovigilance is an advantage but not mandatory
Skills Required
- Basic understanding of pharmacovigilance and drug safety concepts
- Familiarity with healthcare terminology
- Strong attention to detail and documentation accuracy
- Good written and verbal communication skills
- Basic proficiency in MS Office and Windows-based systems
- Willingness to learn global regulations and ICH guidelines
- Strong interest in patient safety and regulatory compliance
Salary & Benefits
- Salary: As per company norms
- Benefits may include:
- Structured training programs
- Career progression in global pharmacovigilance
- Exposure to international safety regulations
- Health and statutory benefits as per company policy
Selection Process
- Application screening
- Technical and functional interviews
- HR discussion
- Final selection based on role suitability and compliance requirements
How to Apply
Interested candidates must apply online through Parexel’s official career portal before the closing date. Applications submitted after the deadline may not be considered. Parexel hiring Patient Safety Associate I
Important Dates
- Application Deadline: 10 February 2026
Why Apply for This Pharma Job?
- Strong entry point into global pharmacovigilance operations
- Exposure to end-to-end drug safety lifecycle activities
- Opportunity to work with international clients and regulatory authorities
- Skill development in safety databases, submissions, and literature review
- Long-term career growth within a globally recognized CRO
Parexel hiring Patient Safety Associate I
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent pharmaceutical job information platform. We are not affiliated with Parexel or any recruiting organization. Job details are shared for informational purposes only. Candidates should apply through official company channels and never pay fees for recruitment. Parexel hiring Patient Safety Associate I
Final Call-to-Action
Candidates aspiring to build a professional career in pharmacovigilance and patient safety should apply promptly before the deadline. Parexel hiring Patient Safety Associate I
