PHARMAFull-time
Medical Writer I / Medical Writer II
By Admin · Medical & Scientific Writing
BANGALORE (IN)HYBRIDPOSTED: 9/30/2026
PHARMAFull-time
HIRING ORGANIZATIONPAREXELBiosciences / Healthcare, Contract Research Organization (CRO)
ROLE OVERVIEW
Develop high-quality pharmacovigilance and regulatory safety documents, conduct signal detection and assessment, synthesize scientific evidence, and support regulatory compliance across the product lifecycle.
ROLE DEFINITION & RESPONSIBILITIES
- •Prepare, compile, and lead scheduled and ad-hoc aggregate safety reports including PSURs, PBRERs, DSURs, and other regulatory safety documents
- •Conduct independent signal detection using safety databases, clinical data, literature, and regulatory websites
- •Prepare Drug Safety Reports and Signal Evaluation Reports using evidence from multiple sources
- •Conduct systematic literature searches and reviews to identify emerging safety trends and support signal evaluation and epidemiology assessments
- •Maintain signal logs, resolve data discrepancies, and ensure safety-data integrity
- •Assist with Risk Management Plans and related documents in alignment with safety data and regulatory requirements
- •Manage client interactions, routine queries, status updates, and escalation of complex issues
- •Maintain audit-ready documentation, archive source materials, and support inspection readiness
- •For Medical Writer II, mentor junior team members, lead complex client discussions, manage document-review cycles, and contribute to process improvement
Reporting Hierarchy: Reports within Parexel's Patient Safety/Medical Writing organization; Exact reporting manager and team size are not specified in the source posting
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- University degree in Life Sciences, Health, or Biomedical Sciences such as Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry, or Physiotherapy, or equivalent training and work experience
- 2+ years of pharmacovigilance, medical writing, or related experience for Medical Writer I
- 4+ years of pharmacovigilance, medical writing, or related experience for Medical Writer II
- Solid understanding of global pharmacovigilance regulations, medical terminology, and safety concepts
- Proficiency in medical writing tools and MS Office
- Familiarity with pharmacovigilance databases and coding dictionaries
- Strong communication, organization, problem-solving, time-management, and prioritization skills
PREFERRED QUALIFICATIONS
- •Prior pharmacovigilance or safety-assessment experience
- •Clinical exposure in hospital environments or direct clinical research experience
- •Expertise in specific therapeutic areas or product types
- •Familiarity with pharmacovigilance systems and regulatory submission processes across multiple regions
REQUIRED VERIFIED SKILLS
Pharmacovigilance
Medical writing
Patient safety
Aggregate safety reports
PSUR
PBRER
DSUR
Signal detection
Signal assessment
Drug Safety Reports
Signal Evaluation Reports
Literature review
Risk Management Plans
MedDRA
WHO-DD
Medical terminology
Global PV regulations
Regulatory compliance
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Flexible hybrid, onsite, and remote work options; continuous learning; career development opportunities; collaborative and patient-focused environment
The source posting does not disclose salary or bonus/equity amounts. No compensation figures have been inferred.
ORGANIZATION CONTEXT & CULTURE
Parexel is a global clinical development partner providing clinical and consulting solutions to the life sciences industry. It states that it has more than 22,000 employees worldwide and supports biopharmaceutical companies and research sites with patient-focused clinical trials and related services.
TEAM SIZE: 22,000+ employees
INDUSTRY: Biosciences / Healthcare, Contract Research Organization (CRO)
Culture: Parexel emphasizes empathy, patient impact, agility, shared purpose, continuous learning, innovation, flexibility, and high standards for clinical research quality.
EXPECTED CAREER ROADMAP
Medical Writer I experience can progress toward Medical Writer II and senior medical-writing or pharmacovigilance positions. Further development in signal management, aggregate reporting, risk management, regulatory strategy, client leadership, and team mentoring can support progression into senior safety-writing, PV management, or specialized patient-safety leadership roles.
APPLICATION ADVISORY
Clearly distinguish Medical Writer I versus Medical Writer II experience in the application; highlight aggregate-report writing such as PSUR, PBRER, or DSUR; demonstrate practical signal detection and assessment experience; emphasize literature review, RMP, MedDRA/WHO-DD, safety databases, and global PV regulations; provide examples of scientific writing, data synthesis, stakeholder communication, and meeting tight regulatory timelines.
RECOMMENDED TRAINING
1/5
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