Parexel Hiring Medical Writer I Patient Safety in the Pharmacovigilance and

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. Parexels 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 .