Parexel Hiring Medical Writer I – Patient Safety (Pharmacovigilance)

Parexel Hiring Medical Writer I – Patient Safety | Life Sciences | Hyderabad

Parexel is currently hiring for the role of Medical Writer I – Patient Safety for candidates with a background in life sciences, pharmacy, biotechnology, microbiology, biomedical sciences, and related healthcare domains. This opportunity is ideal for professionals interested in pharmacovigilance jobs, drug safety operations, medical writing careers, and regulatory documentation roles within the global clinical research industry.

The company is offering opportunities in Hyderabad, Bengaluru, and remote work models in India. Candidates with prior exposure to pharmacovigilance, safety writing, aggregate reporting, signal detection, and risk management documentation are encouraged to apply. Professionals looking for clinical safety writing jobs, PV documentation careers, or regulatory medical writing roles in CRO companies can find strong long-term career growth through this opening.

Company Overview

Parexel is a globally recognized Clinical Research Organization (CRO) providing advanced drug development, pharmacovigilance, regulatory consulting, clinical operations, and medical affairs solutions to pharmaceutical, biotechnology, and healthcare companies worldwide. The company supports drug safety monitoring, risk management, regulatory submissions, and clinical development activities across multiple therapeutic areas.

Parexel has established itself as a trusted name in the clinical research and pharmacovigilance industry by supporting global pharmaceutical companies with regulatory compliance, safety reporting, and patient-centric healthcare solutions. Professionals working at Parexel gain exposure to international pharmacovigilance systems, global safety databases, aggregate reporting frameworks, and regulated market documentation standards.

This Medical Writer I – Patient Safety role is particularly valuable for candidates aiming to build careers in pharmacovigilance, drug safety surveillance, clinical documentation, and medical communications.

Job Role & Responsibilities

The Medical Writer I – Patient Safety role involves preparation, review, analysis, and coordination of safety-related regulatory documentation and pharmacovigilance reports. Candidates will work closely with cross-functional teams including safety physicians, regulatory affairs teams, quality departments, and global stakeholders.

Aggregate Safety Reporting Responsibilities

Selected candidates will contribute to the preparation and compilation of:

• Periodic Safety Update Reports (PSURs)
• Periodic Benefit Risk Evaluation Reports (PBRERs)
• Development Safety Update Reports (DSURs)
• Periodic Adverse Drug Experience Reports (PADERs)
• Semi-Annual Safety Reports (SASRs)
• Addendum to Clinical Overviews (ACOs)
• Annual Risk Benefit Evaluation Reports
• Safety statements and regulatory safety documentation

Candidates will also:

• Review and incorporate feedback into safety report drafts
• Ensure consistency and data integrity across documentation
• Coordinate submission activities with regulatory authorities
• Prepare comparison documents and labeling support documents
• Support appendices and medical safety documentation processes

Safety Analysis & Signal Management

Professionals selected for this pharmacovigilance role will:

• Conduct signal detection and signal evaluation activities
• Analyze safety data from clinical databases and literature sources
• Support quantitative and qualitative safety analysis
• Maintain signal tracking logs and documentation
• Review medical literature for safety evaluations
• Assist in preparation of Signal Evaluation Reports (SERs)
• Support Drug Safety Reports (DSRs)
• Resolve discrepancies in safety datasets and line listings

Risk Management & Compliance Activities

The role also includes:

• Assisting in Risk Management Plan (RMP) preparation
• Supporting pharmacovigilance compliance activities
• Maintaining audit-ready documentation
• Supporting inspection readiness activities
• Ensuring compliance with global pharmacovigilance guidelines
• Collaborating with international stakeholders and client teams

Scientific Writing & Documentation Support

Candidates should demonstrate:

• Strong scientific writing and medical documentation skills
• Knowledge of medical terminology and pharmacovigilance concepts
• Familiarity with MedDRA and WHO-DD coding dictionaries
• Ability to manage timelines and multiple projects
• Strong analytical thinking and communication abilities

This role provides excellent exposure to high-demand pharmaceutical domains such as:

• Drug safety operations
• Pharmacovigilance documentation
• Clinical safety writing
• Global regulatory compliance
• Medical communications
• Aggregate safety reporting
• Signal detection and management
• Risk management planning

Eligibility / Qualifications

Parexel is looking for candidates with educational backgrounds in life sciences, healthcare, pharmacy, or biomedical sciences.

Required Educational Qualifications

Eligible qualifications include:

• B.Pharm
• M.Pharm
• Pharm.D
• B.Sc Life Sciences
• M.Sc Life Sciences
• Biotechnology
• Microbiology
• Biochemistry
• Biomedical Sciences
• Biophysics
• Physiotherapy
• Dentistry
• Healthcare Sciences

Candidates with clinical exposure or hospital-based experience may receive additional preference.

Preferred Skills

Candidates should possess:

• Knowledge of pharmacovigilance processes
• Understanding of global safety regulations
• Strong medical writing abilities
• Expertise in safety data analysis
• Documentation and compliance skills
• Good communication and collaboration skills
• Familiarity with regulatory reporting standards
• MS Office proficiency
• Attention to detail and analytical thinking

Experience Requirement

• Prior pharmacovigilance or drug safety experience is preferred
• Freshers with strong medical writing or safety documentation exposure may also apply depending on project requirements
• Experience in aggregate reporting or signal management will be advantageous

Location & Salary

Job Location

• Hyderabad
• Bengaluru
• Remote (India)

Expected Salary

Based on current pharmaceutical industry standards and CRO market trends in India, the approximate salary for Medical Writer I – Patient Safety roles may range between:

• ₹4.5 LPA to ₹8.5 LPA for candidates with relevant experience
• Higher compensation may be offered depending on pharmacovigilance expertise and aggregate reporting experience

Additional benefits may include:

• Global project exposure
• Hybrid or remote work flexibility
• Learning and development programs
• International pharmacovigilance training
• Career progression within clinical research and drug safety domains

Application Process

Interested candidates can apply directly through the official Parexel careers portal using the application link below:

Apply Here: https://jobs.parexel.com/en/job/hyderabad/medical-writer-i-patient-safety/877/95373938528

Candidates are advised to:

• Update their latest resume before applying
• Highlight pharmacovigilance or safety writing experience clearly
• Mention aggregate reporting exposure if available
• Include knowledge of PSUR, DSUR, PBRER, or signal management activities
• Mention experience with MedDRA or WHO-DD coding if applicable

Frequently Asked Questions (FAQs)

1. What is the role offered by Parexel?

Parexel is hiring for the position of Medical Writer I – Patient Safety.

2. Who can apply for this pharmacovigilance role?

Candidates with qualifications in Pharmacy, Biotechnology, Microbiology, Biochemistry, Biomedical Sciences, Life Sciences, Physiotherapy, Dentistry, and related healthcare fields can apply.

3. Is prior pharmacovigilance experience mandatory?

Prior experience is preferred, especially in pharmacovigilance, aggregate safety reporting, or drug safety documentation. However, candidates with strong scientific writing skills may also be considered.

4. What are the work locations available?

The opportunity is available in Hyderabad, Bengaluru, and remote work locations across India.

5. What is the expected salary for Medical Writer I roles?

The estimated salary may range from ₹4.5 LPA to ₹8.5 LPA depending on experience, pharmacovigilance expertise, and medical writing exposure.

6. Which pharmacovigilance reports are handled in this role?

Candidates may work on PSURs, PBRERs, DSURs, PADERs, SASRs, safety statements, signal evaluation reports, and risk management documentation.

Summary

Company	Parexel
Department Vacancies	Medical Writer I – Patient Safety
Qualification	B.Pharm, M.Pharm, Pharm.D, BSc, MSc, Biotechnology, Microbiology, Biochemistry, Biomedical Sciences, Physiotherapy, Dentistry
Experience	Freshers to Experienced Candidates with Pharmacovigilance or Safety Writing Exposure
Location	Hyderabad, Bengaluru, Remote India

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