Parexel Fresher Pharmacovigilance Hiring Patient Safety Associate I
- Parexel Hiring Patient Safety Associate I | Freshers & Experienced | Hyderabad & Mohali
- Company Overview
- Job Role & Responsibilities
- Key Responsibilities:
- Eligibility / Qualifications
- Educational Qualification:
- Relevant Courses:
- Experience:
- Required Skills
- Location & Salary
- Application Process
- Frequently Asked Questions (FAQs)
- Who can apply for this role?
- Is prior pharmacovigilance experience required?
- What is ICSR in pharmacovigilance?
- What career growth can I expect?
- Where is the job located?
Parexel Hiring Patient Safety Associate I | Freshers & Experienced | Hyderabad & Mohali
Parexel is currently hiring for the role of Patient Safety Associate I in the Pharmacovigilance and Drug Safety department with openings in Hyderabad and Mohali. This opportunity is open for freshers and candidates with relevant healthcare or clinical research experience who are looking to build a career in pharmacovigilance, drug safety, and clinical data management. This role plays a critical part in ensuring patient safety through accurate adverse event reporting and regulatory compliance in the pharmaceutical industry.
Company Overview
Parexel is a globally trusted clinical research organization (CRO) known for delivering end-to-end drug development, regulatory consulting, and pharmacovigilance services. The company works with top biopharmaceutical and medical device organizations to bring safe and effective therapies to patients worldwide. With a strong focus on compliance, innovation, and patient-centric solutions, Parexel provides an ideal platform for professionals entering the clinical research and drug safety domain.
The organization is recognized for its structured training programs, global exposure, and commitment to healthcare advancement. Employees at Parexel contribute directly to improving patient outcomes by supporting critical stages of clinical trials and post-marketing safety monitoring.
Job Role & Responsibilities
As a Patient Safety Associate I, you will be involved in pharmacovigilance operations including Individual Case Safety Report (ICSR) processing, safety data management, regulatory submissions, and literature review. This role requires high attention to detail and a strong understanding of drug safety and compliance standards.
Key Responsibilities:
ICSR Processing & Case Management
- Monitor incoming safety reports from sources like EudraVigilance, literature, and internal databases
- Perform data entry and case creation in safety databases
- Ensure accurate MedDRA coding and clinical data capture
- Prepare Adverse Drug Reaction (ADR) reports and case narratives
- Conduct quality checks and validation of safety cases
- Handle follow-ups and query management for incomplete cases
Safety Reporting & Regulatory Compliance
- Submit ICSRs and periodic safety reports to regulatory authorities and stakeholders
- Ensure compliance with global pharmacovigilance guidelines and reporting timelines
- Support audit readiness and regulatory inspections
- Maintain compliance metrics and reporting schedules
- Assist in preparation of safety documentation in eTMF/EDMS systems
Literature Review & Signal Detection
- Perform scientific literature searches to identify adverse drug reactions
- Screen and review articles for safety signals and emerging risks
- Maintain and update literature search strategies
- Support signal detection and regulatory reporting activities
Affiliate & Regulatory Support
- Coordinate with global and local affiliates for safety data exchange
- Assist in regulatory submissions, product registrations, and lifecycle management
- Support compliance with country-specific pharmacovigilance requirements
- Maintain regulatory databases and safety reporting systems
General Responsibilities
- Follow SOPs and regulatory workflows
- Participate in training and learning programs
- Collaborate with cross-functional teams
- Ensure timely documentation and reporting
Eligibility / Qualifications
Educational Qualification:
Degree in Life Sciences, Pharmacy, Biomedical Sciences, or related disciplines
Relevant Courses:
B.Pharmacy, M.Pharmacy, Pharm.D, BSc Life Sciences, MSc Life Sciences, Biotechnology, Microbiology, Biochemistry, Biomedical Sciences, Clinical Research
Experience:
- Freshers or candidates with relevant experience in pharmacovigilance, clinical research, or healthcare can apply
- Basic understanding of drug safety and ICH guidelines is preferred
Required Skills
- Strong analytical and problem-solving abilities
- Knowledge of pharmacovigilance and drug safety concepts
- Good communication and documentation skills
- Attention to detail and accuracy in data handling
- Familiarity with safety databases and MS Office tools
Location & Salary
- Job Location: Hyderabad and Mohali, India
- Salary: Competitive salary package as per industry standards in pharmacovigilance and clinical research roles
Application Process
Interested candidates can apply through the official Parexel careers portal using the link below:
Apply Here: https://jobs.parexel.com/en/job/-/-/877/92294780240
Frequently Asked Questions (FAQs)
Who can apply for this role?
Candidates with Life Sciences, Pharmacy, or Biomedical degrees, including freshers, are eligible.
Is prior pharmacovigilance experience required?
No, freshers can apply. However, basic knowledge of drug safety concepts is beneficial.
What is ICSR in pharmacovigilance?
ICSR stands for Individual Case Safety Report, which involves documenting adverse drug reactions reported by patients or healthcare professionals.
What career growth can I expect?
You can grow into roles such as Drug Safety Associate, Senior PV Specialist, Signal Detection Expert, or Regulatory Affairs Specialist.
Where is the job located?
The role is based in Hyderabad and Mohali.
| Category | Details |
|---|---|
| Company | Parexel |
| Vacancies | Patient Safety Associate I |
| Required Education | Life Sciences / Pharmacy / Biomedical Sciences |
| Experience | Freshers & Experienced |
To apply for this job please visit jobs.parexel.com.
