Pharmacovigilance Patient Safety Associate II Hiring | Parexel
- Parexel Hiring Patient Safety Associate II | Pharmacovigilance Jobs in India Apply Now
- Company Overview
- Job Role & Responsibilities
- Pharmacovigilance & ICSR Processing
- Safety Reporting & Regulatory Compliance
- Literature Review & Signal Detection
- Affiliate & Regulatory Support
- Quality & Process Improvement
- Eligibility / Qualifications
- Educational Qualification:
- Experience:
- Skills Required:
- Location & Salary
- Application Process
- Frequently Asked Questions (FAQs)
- What is the role of a Patient Safety Associate II?
- Who can apply for this role?
- Is prior pharmacovigilance experience mandatory?
- What skills are important for this job?
- What is the career scope in pharmacovigilance?
Parexel Hiring Patient Safety Associate II | Pharmacovigilance Jobs in India Apply Now
Parexel is hiring for the role of Patient Safety Associate II across its Medical Sciences and Pharmacovigilance department with job locations in Mohali and Hyderabad. This opportunity is ideal for candidates with around 2 years of experience in pharmacovigilance who are looking to advance their careers in drug safety, case processing, and regulatory compliance within a global CRO environment.
This role plays a critical part in ensuring patient safety through adverse event reporting, ICSR processing, regulatory submissions, and safety data management across clinical trials and post-marketing surveillance programs.
Company Overview
Parexel is a globally recognized Clinical Research Organization (CRO) that provides end-to-end clinical development services including clinical trials, regulatory consulting, pharmacovigilance, and market access solutions. With a strong global presence, Parexel supports pharmaceutical and biotechnology companies in bringing innovative therapies to market while ensuring compliance with global regulatory standards.
The company is known for its expertise in drug safety, data-driven clinical development, and patient-focused research, making it a preferred employer in the life sciences and healthcare domain.
Job Role & Responsibilities
Pharmacovigilance & ICSR Processing
- Perform Individual Case Safety Report (ICSR) processing and data entry in safety databases
- Validate seriousness, causality, and expectedness of adverse events
- Conduct MedDRA coding and prepare detailed case narratives
- Manage follow-ups and query resolution for safety cases
Safety Reporting & Regulatory Compliance
- Support submission of safety reports to global regulatory authorities
- Ensure compliance with ICH guidelines and reporting timelines
- Assist in periodic safety report generation and reconciliation activities
- Maintain accurate documentation and audit readiness
Literature Review & Signal Detection
- Perform literature search and screening for adverse drug reactions
- Identify safety signals and escalate for medical review
- Maintain databases and update search strategies
Affiliate & Regulatory Support
- Coordinate with global affiliates for safety data exchange
- Support regulatory submissions and product lifecycle updates
- Assist in safety intelligence and regulatory intelligence activities
Quality & Process Improvement
- Conduct quality checks and validation of safety data
- Support audits, inspections, and compliance metrics tracking
- Participate in process improvement initiatives
Eligibility / Qualifications
Educational Qualification:
Degree in Life Sciences or Health Sciences
Relevant Courses: B.Pharm, M.Pharm, BSc Microbiology, BSc Biotechnology, BSc Biochemistry, MSc Life Sciences, Pharm D, Biomedical Sciences
Experience:
- Minimum 2 years of experience in Pharmacovigilance
Skills Required:
- Knowledge of ICH-GCP and pharmacovigilance regulations
- Understanding of safety databases and case processing workflows
- Good medical terminology knowledge
- Strong analytical and documentation skills
- Proficiency in MS Office and safety systems
Location & Salary
- Job Location: Mohali, Hyderabad
- Work Type: Full-time
- Salary: Not disclosed (competitive as per industry standards)
Application Process
Interested candidates can apply directly using the official link below:
Apply Here: https://jobs.parexel.com/en/job/-/-/877/94031919984
Frequently Asked Questions (FAQs)
What is the role of a Patient Safety Associate II?
It involves handling pharmacovigilance activities such as ICSR processing, safety reporting, and regulatory compliance.
Who can apply for this role?
Candidates with a life sciences background and at least 2 years of pharmacovigilance experience.
Is prior pharmacovigilance experience mandatory?
Yes, a minimum of 2 years of relevant experience is required.
What skills are important for this job?
Knowledge of drug safety processes, regulatory guidelines, and strong analytical skills.
What is the career scope in pharmacovigilance?
Pharmacovigilance offers strong growth in drug safety, regulatory affairs, and clinical research domains.
| Category | Details |
|---|---|
| Company | Parexel |
| Vacancies | Patient Safety Associate II |
| Required Education | B.Pharm, M.Pharm, BSc, MSc, Pharm D |
| Experience | 2 Years Pharmacovigilance Experience |
To apply for this job please visit jobs.parexel.com.
