Parexel Hiring Medical Writer I – Patient Safety in the Pharmacovigilance and Drug Safety
- Parexel Hiring Medical Writer I – Patient Safety in Bengaluru | Life Sciences Apply 2026
- Company Overview
- Job Role & Responsibilities
- Safety Medical Writing & Aggregate Safety Reports
- Safety Analysis & Signal Management
- Risk Management & Compliance Support
- Client & Cross-Functional Collaboration
- Eligibility & Qualifications
- Educational Background
- Experience & Knowledge Requirements
- Location & Employment Details
- Application Process
- Career Scope in Medical Writing & Pharmacovigilance
- Frequently Asked Questions (FAQs)
- 1. Is prior pharmacovigilance experience mandatory?
- 2. What reports will the Medical Writer handle?
- 3. Is this a clinical research role?
- 4. What coding dictionaries should candidates know?
- 5. What career growth can be expected?
- Summary Table
Parexel Hiring Medical Writer I – Patient Safety in Bengaluru | Life Sciences Apply 2026
Parexel is inviting applications for the position of Medical Writer I – Patient Safety in the Pharmacovigilance and Drug Safety department at its Bengaluru, India location. This is a full-time opportunity for life sciences and healthcare graduates who want to build a long-term career in medical writing, drug safety analysis, regulatory documentation, and global pharmacovigilance operations. The role is open to candidates with prior experience in pharmacovigilance or related safety domains and offers direct exposure to global aggregate safety reporting and signal detection activities.
If you are aiming to work in clinical research, regulatory affairs, safety data analysis, and risk management within a globally recognized CRO, this position offers strong career growth in high-demand healthcare and pharmaceutical development services.
Company Overview
entity[“organization”,”Parexel”,”global cro company”] is a leading global clinical research organization (CRO) providing end-to-end clinical development, regulatory consulting, and market access solutions to pharmaceutical, biotechnology, and medical device companies. With decades of experience in drug development and regulatory strategy, Parexel plays a critical role in bringing innovative therapies to patients worldwide.
The organization supports sponsors across early-phase research, clinical trial management, pharmacovigilance, medical writing, biostatistics, regulatory submissions, and post-marketing safety surveillance. Parexel’s patient-focused approach and strong compliance framework make it a trusted partner for global regulatory authorities and life sciences companies.
Working at Parexel means contributing to therapies that directly impact patient health. Every safety report, risk management document, and regulatory submission supports better treatment decisions and safer medicines worldwide.
Job Role & Responsibilities
The Medical Writer I – Patient Safety will support aggregate safety reporting, signal detection, risk management documentation, and regulatory safety submissions. This role sits within pharmacovigilance and requires strong analytical thinking, scientific writing skills, and knowledge of global drug safety regulations.
Safety Medical Writing & Aggregate Safety Reports
- Prepare and compile scheduled and ad-hoc aggregate safety reports including PSURs, PBRERs, DSURs, PADERs, SASRs, ARBE reports, safety statements, and Addendum to Clinical Overviews.
- Lead simple safety reports independently and support medium-complexity reports under supervision.
- Incorporate cross-functional review feedback and ensure data consistency and integrity across documents.
- Coordinate safety document submissions to regulatory authorities across multiple global regions.
- Prepare supporting documentation such as labeling comparison documents, INN checks, and appendices.
Safety Analysis & Signal Management
- Perform signal detection activities using clinical databases, literature sources, and regulatory data.
- Conduct quantitative and qualitative safety data analysis to identify potential safety signals.
- Maintain signal tracking logs and ensure documentation accuracy.
- Contribute to Drug Safety Reports (DSRs) and Signal Evaluation Reports (SERs).
- Conduct literature reviews to support periodic safety reports and epidemiology assessments.
- Identify and resolve discrepancies in safety data listings to maintain data integrity.
Risk Management & Compliance Support
- Assist in preparation and updates of Risk Management Plans (RMPs).
- Maintain audit-ready documentation aligned with global pharmacovigilance standards.
- Support inspection readiness activities.
- Ensure compliance with international regulatory guidelines and internal SOPs.
Client & Cross-Functional Collaboration
- Manage routine client queries independently and escalate complex issues appropriately.
- Provide proactive updates on project timelines and document cycles.
- Collaborate with global stakeholders across clinical operations, regulatory affairs, and safety teams.
This position requires accuracy, structured thinking, and the ability to interpret complex safety datasets while delivering clear, regulatory-compliant documentation.
Eligibility & Qualifications
Educational Background
Candidates should possess a university degree in Life Sciences, Health Sciences, or Biomedical Sciences. Relevant qualifications include:
B.Pharm, M.Pharm, Pharm.D, BSc Microbiology, MSc Microbiology, BSc Biochemistry, MSc Biochemistry, BSc Biotechnology, MSc Biotechnology, BSc Biophysics, MSc Biophysics, BDS (Dentistry), BPT (Physiotherapy), MSc Life Sciences, Clinical Research, Biomedical Sciences, or equivalent training and work experience.
Clinical exposure in hospital-based environments will be considered an advantage.
Experience & Knowledge Requirements
- Prior experience in pharmacovigilance, drug safety, or related healthcare domains preferred.
- Good understanding of global pharmacovigilance regulations and safety reporting standards.
- Familiarity with MedDRA and WHO-DD coding dictionaries.
- Strong medical terminology knowledge.
- Proficiency in MS Office and medical writing tools.
- Excellent analytical, documentation, and communication skills.
- Ability to manage multiple regulatory documents while meeting strict timelines.
Candidates aiming for long-term growth in regulatory writing, safety data analytics, and clinical research consulting will benefit significantly from this opportunity.
Location & Employment Details
- Location: Bengaluru, India
- Employment Type: Full-Time
- Application Deadline: February 18, 2026
Application Process
Interested candidates should apply through Parexel’s official career portal using the link below:
Early applications are recommended as the deadline is approaching soon.
Career Scope in Medical Writing & Pharmacovigilance
Medical writing and drug safety roles are among the fastest-growing career paths in clinical research and pharmaceutical services. With increasing global regulatory scrutiny and emphasis on patient safety, demand for skilled professionals in aggregate safety reporting, risk management planning, and signal detection continues to rise.
Experience gained in this role can lead to advanced positions such as Senior Medical Writer, Pharmacovigilance Scientist, Drug Safety Associate, Regulatory Affairs Specialist, and Global Safety Lead. Professionals in this field contribute directly to patient safety, regulatory compliance, and responsible drug development.
Frequently Asked Questions (FAQs)
1. Is prior pharmacovigilance experience mandatory?
Prior experience is preferred but candidates with strong safety knowledge and relevant academic backgrounds may also be considered.
2. What reports will the Medical Writer handle?
The role includes PSURs, PBRERs, DSURs, PADERs, safety statements, signal evaluation reports, and risk management plans.
3. Is this a clinical research role?
Yes, it is part of clinical development support focused on safety surveillance and regulatory documentation.
4. What coding dictionaries should candidates know?
Familiarity with MedDRA and WHO-DD is important for pharmacovigilance activities.
5. What career growth can be expected?
Professionals can progress to senior safety writing, global pharmacovigilance leadership, or regulatory consulting roles.
Summary Table
| Company | Parexel |
| Vacancies | Medical Writer I – Patient Safety |
| Required Education | B.Pharm, M.Pharm, Pharm.D, BSc/MSc Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry, Physiotherapy, Life Sciences, Clinical Research |
| Experience | Prior pharmacovigilance or drug safety experience preferred |
To apply for this job please visit wd1.myworkdaysite.com.
