Are you a life sciences graduate looking to begin your journey in pharmacovigilance and drug safety? Here’s a promising opportunity to work with a globally recognized Clinical Research Organization in Hyderabad, India.
🏢 About Parexel
Parexel is a leading global Clinical Research Organization (CRO) that partners with pharmaceutical, biotechnology, and medical device companies to develop innovative therapies.
From:
- Clinical trial management
- Regulatory consulting
- Pharmacovigilance & safety reporting
- Medical affairs support
Parexel plays a vital role in bringing safe and effective treatments to patients worldwide.
If you are passionate about global healthcare compliance and patient safety, this is a strong entry point into the clinical research industry.
📍 Job Details
- Location: Hyderabad, India
- Role: Patient Safety Associate I
- Department: Pharmacovigilance (PV)
- Employment Type: Full-Time
- Experience Level: Entry-Level / Freshers Eligible
👩⚕️ Role Overview – Patient Safety Associate I
This is an entry-level pharmacovigilance position focused on:
- Processing adverse event reports
- Reviewing safety data
- Ensuring regulatory compliance
- Supporting global safety submissions
Ideal for graduates in:
- B.Pharm / M.Pharm
- Biotechnology
- Microbiology
- Biochemistry
- Biomedical Sciences
- Life Sciences
🔍 Key Responsibilities
🧾 1. ICSR Processing (Individual Case Safety Reports)
This is the core function of pharmacovigilance.
- Monitor incoming safety reports (emails, portals, literature)
- Perform case triage and validity checks
- Enter data into safety databases
- Apply proper MedDRA coding
- Draft medically accurate case narratives
- Perform quality control and validation
- Ensure compliance with reporting timelines
👉 This ensures regulatory compliance and protects patient safety globally.
📑 2. Safety Submissions
- Submit ICSRs to health authorities
- Support periodic safety reports
- Track regulatory submission timelines
- Coordinate with sponsors and internal teams
- Assist in audits and inspections
This provides exposure to global regulatory systems such as US FDA, EMA, and other health authorities.
📚 3. Literature Search & Review
- Develop literature search strategies
- Screen articles for Adverse Drug Reactions (ADRs)
- Identify potential safety signals
- Maintain journal tracking systems
- Conduct peer review & quality checks
Literature surveillance is essential for signal detection and continuous safety monitoring.
🌍 4. Affiliate & Regulatory Support
- Communicate with global affiliates
- Assist in product lifecycle updates
- Support eCTD submissions
- Track safety documents like:
- RMP (Risk Management Plan)
- PBRER (Periodic Benefit-Risk Evaluation Report)
- PASS (Post-Authorization Safety Study)
- Maintain regulatory databases
This builds strong expertise in international compliance.
🧠 Skills Required
To succeed in this role, you should have:
- Basic knowledge of pharmacovigilance
- Understanding of drug safety regulations
- Strong analytical skills
- Attention to detail
- Good communication skills
- MS Office proficiency
- Ability to meet strict deadlines
Freshers with strong learning ability are encouraged to apply.
🎓 Educational Qualification
Eligible degrees include:
- B.Pharm / M.Pharm
- Biotechnology
- Microbiology
- Biochemistry
- Biomedical Sciences
- Life Sciences
- Other related healthcare disciplines
Experience in pharmacovigilance is a plus, but not mandatory.
🚀 Career Growth in Pharmacovigilance
Starting as a Patient Safety Associate can lead to roles such as:
- Drug Safety Specialist
- Safety Scientist
- Medical Reviewer
- Regulatory Affairs Associate
- Signal Detection Expert
- PV Team Lead
With growing regulatory scrutiny worldwide, demand for skilled pharmacovigilance professionals continues to rise.
🌟 Why Consider This Role?
✔ Work with a global CRO
✔ International regulatory exposure
✔ Strong pharmacovigilance foundation
✔ Exposure to global reporting systems
✔ Career advancement opportunities
✔ Direct contribution to patient safety
📌 Final Thoughts
The Patient Safety Associate I role at Parexel in Hyderabad is an excellent opportunity for life sciences graduates to build a strong foundation in drug safety and pharmacovigilance.
If you are detail-oriented, compliance-focused, and passionate about improving global healthcare standards, this role could be your ideal starting point in the clinical research industry.
🔗 Apply Here:
