Life Science Jobs at Parexel | Candidates Apply Now
Are you looking for Life Science Jobs, Medical Writer Jobs, or exciting opportunities through Parexel Careers? Parexel is hiring for the Medical Writer-II, Patient Safety role in India. This opportunity is ideal for candidates with a background in Life Sciences, Pharmacovigilance, Biotechnology, Pharmacy, Microbiology, and related biomedical fields who want to build a rewarding career in medical writing and patient safety. Explore this exciting job opening and apply now to grow your career with a globally recognized organization.
About Parexel
Parexel is a leading global Clinical Research Organization (CRO) that provides innovative solutions to the biopharmaceutical and medical device industries. The company specializes in clinical research, regulatory consulting, pharmacovigilance, and market access services. With a strong global presence, Parexel supports the development of life-changing therapies while offering excellent career growth opportunities in Life Science Jobs and Medical Writer Jobs worldwide.
Job Details
- Company: Parexel
- Role: Medical Writer-II, Patient Safety
- Location: Hyderabad, Bengaluru, Remote India
- Category: Medical Sciences
- Job ID: R0000042167
Key Responsibilities
- Safety Medical Writing & Analysis
- Prepare aggregate safety reports, including PSURs, PBRERs, DSURs, PADERs, and related safety documents.
- Lead medium-complexity reports and support complex report development.
- Review safety documents for accuracy, compliance, and consistency.
- Coordinate regulatory submissions and labeling comparison documents.
- Signal Detection & Safety Analysis
- Perform signal detection and advanced safety data analysis.
- Manage signal tracking activities and prepare DSRs/SERs.
- Conduct literature reviews for drug safety reports and RMPs.
- Resolve complex safety data discrepancies systematically.
- Risk Management Support
- Support development and updates of RMPs and CC-RMPs.
- Collaborate with cross-functional teams for compliant RMP preparation.
- Scientific & Project Support
- Apply expertise in safety profiles, MedDRA, and WHO-DD coding systems.
- Ensure high-quality deliverables and manage multiple projects effectively.
- Participate in safety strategy discussions and maintain audit-ready documentation.
- Client Engagement & Communication
- Serve as the primary client contact for assigned projects.
- Lead client discussions and manage cross-functional review cycles.
- Support effective global communication and collaboration.
- Quality & Compliance
- Ensure regulatory compliance across deliverables.
- Review junior team members’ work and recommend process improvements.
- Participate in audits, inspections, and KPI/SLA monitoring.
- Training & Innovation
- Mentor junior team members and deliver safety writing training.
- Support new technologies and process improvement initiatives.
- Share best practices to improve operational efficiency and writing quality.
Qualifications
- University degree in Life Sciences, Health, or Biomedical Sciences.
- Preferred backgrounds include Pharmacy, Biotechnology, Microbiology, Biochemistry, Biophysics, Dentistry, Physiotherapy, or related fields.
- Equivalent training and work experience may also be considered.
- Clinical exposure in hospital-based environments is advantageous.
Experience Required
- Prior experience in Pharmacovigilance or related fields is preferred.
- Strong understanding of global pharmacovigilance regulations and safety-related concepts.
- Experience in medical writing, aggregate safety reports, and regulatory documentation is beneficial.
Skills Needed
- Strong analytical thinking and problem-solving abilities.
- Excellent scientific writing and communication skills.
- Effective collaboration and interpersonal communication skills.
- Strong organizational and time-management abilities.
- Proficiency in MS Office applications and medical writing tools.
- Familiarity with pharmacovigilance databases and coding dictionaries like MedDRA and WHO-DD.
- Adaptability and a continuous learning mindset.
If you are searching for Life Science Jobs, Medical Writer Jobs, or exciting opportunities through Parexel Careers, this Medical Writer-II, Patient Safety role at Parexel could be the perfect opportunity to advance your career in pharmacovigilance and medical sciences.
