Parexel Fresher Pharmacovigilance Hiring | Patient Safety Associate
- Patient Safety Associate Fresher – Hyderabad
- Company Overview
- Job Role & Responsibilities
- General Pharmacovigilance Responsibilities
- ICSR Processing & Case Management
- Safety Reporting & Submissions
- Literature Surveillance & Signal Support
- Affiliate & Regulatory Support Activities
- Eligibility / Qualifications
- Location & Salary
- Application Process
- Frequently Asked Questions
- Is this role suitable for freshers?
- Is this a permanent position?
- Is pharmacovigilance experience mandatory?
- Is this an office-based role?
- Are there growth opportunities after the contract?
Patient Safety Associate Fresher – Hyderabad
MPharm/PharmD/BDS freshers required for Patient Safety Associate I vacancies at Parexel, Hyderabad/Mohali.
Patient safety and pharmacovigilance are core pillars of modern drug development, ensuring that medicines are continuously monitored for safety throughout their lifecycle. Parexel is currently hiring Patient Safety Associate I professionals for its Hyderabad and Mohali offices. This entry-level opportunity is designed specifically for fresh graduates who want to start their careers in pharmacovigilance, drug safety operations, and global regulatory compliance within a leading clinical research organization.
Company Overview
Parexel is a globally recognized clinical research organization providing end-to-end clinical development solutions to pharmaceutical, biotechnology, and medical device companies. From early-phase clinical trials to regulatory submissions and post-marketing safety surveillance, Parexel supports the full development lifecycle of innovative therapies.
Driven by a patient-first philosophy, Parexel combines scientific expertise, regulatory knowledge, and operational excellence to help sponsors bring safe and effective treatments to patients worldwide. With operations across multiple regions, Parexel is known for its strong ethical culture, quality-driven processes, and deep commitment to improving global health outcomes.
Job Role & Responsibilities
The Patient Safety Associate I role is a full-time, office-based contractual position focused on Individual Case Safety Report processing, safety reporting, literature surveillance, and regulatory compliance activities.
General Pharmacovigilance Responsibilities
• Develop foundational knowledge of product safety profiles, labeling, and global pharmacovigilance regulations
• Follow project-specific workflows, standard operating procedures, and reporting timelines
• Support compliance with global regulatory reporting requirements
• Assist in preparation for audits and inspections under supervision
• Participate in internal and client-specific training programs through the Learning Management System
• Ensure timely and accurate completion of timesheets and documentation
ICSR Processing & Case Management
• Monitor incoming safety reports from sources such as safety mailboxes, EudraVigilance, and literature databases
• Perform triage of incoming reports for completeness, validity, and legibility
• Enter valid cases into safety databases following client conventions and SOPs
• Create cases, perform data entry, and advance cases through workflow stages
• Prepare Adverse Drug Reaction forms and medically cohesive case narratives
• Perform MedDRA coding in line with term selection guidelines
• Assess seriousness, causality, and expectedness of adverse events
• Request follow-ups and manage queries related to incomplete safety information
• Perform quality and validation checks on processed cases
Safety Reporting & Submissions
• Submit Individual Case Safety Reports and periodic safety reports to health authorities and ethics committees
• Support expedited and aggregate safety reporting activities
• Maintain reporting schedules and support on-time submission compliance
• Perform unblinding of treatment codes for safety reporting when required
• Prepare and file project documentation in electronic document management systems
• Support audits, inspections, and regulatory interactions as designated
Literature Surveillance & Signal Support
• Conduct literature searches based on approved search strategies
• Screen scientific publications for potential adverse drug reactions and safety signals
• Prepare and review literature abstracts and summaries
• Support signal detection activities by flagging relevant safety findings
• Maintain local journal lists and update search strategies as required
Affiliate & Regulatory Support Activities
• Support communication between global safety teams and local affiliates
• Assist with regulatory applications, registrations, and lifecycle updates
• Support electronic reporting registrations and portal setup for sponsors
• Assist with data reconciliation, compliance metrics, and follow-up activities
• Maintain regulatory intelligence trackers and safety reporting databases
Eligibility / Qualifications
This role is designed for recent graduates seeking entry-level pharmacovigilance jobs.
Required qualifications:
• MPharm, PharmD, or BDS
• Year of passing: 2025
• Basic understanding of pharmacovigilance and drug safety concepts
• Strong written and verbal communication skills
• Willingness to work in an office-based environment
• Ability to learn global regulations including ICH guidelines
Relevant educational background includes:
MPharm, PharmD, BDS, MSc Pharmacology, MSc Clinical Research, Biotechnology, Microbiology, Biochemistry
No prior pharmacovigilance experience is mandatory, making this an ideal fresher pharmacovigilance role.
Location & Salary
Job Location: Hyderabad or Mohali
This is a full-time, office-based role offered on a one-year contractual basis. Salary details are not publicly disclosed; however, Parexel offers competitive entry-level compensation aligned with pharmacovigilance and clinical research industry standards.
Professionals can expect:
• Structured onboarding and pharmacovigilance training
• Exposure to global drug safety operations
• Experience working on international regulatory submissions
• Strong foundation for long-term careers in patient safety and pharmacovigilance
Application Process
Eligible candidates can apply directly through the official Parexel careers portal using the link below:
Shortlisted candidates will be contacted by the recruitment team for further steps in the selection process.
Frequently Asked Questions
Is this role suitable for freshers?
Yes. This role is specifically designed for fresh graduates with basic pharmacovigilance knowledge.
Is this a permanent position?
No. This is a one-year contractual role.
Is pharmacovigilance experience mandatory?
No. Basic understanding of drug safety concepts is sufficient.
Is this an office-based role?
Yes. This is a full-time office-based role.
Are there growth opportunities after the contract?
Yes. High-performing associates may be considered for extended or permanent roles based on business needs.
| Category | Details |
|---|---|
| Company | Parexel |
| Vacancies | Patient Safety Associate I |
| Required Education | MPharm, PharmD, BDS |
| Experience | Fresher |
To apply for this job please visit wd1.myworkdaysite.com.
