Senior Medical Writer – Pharmacovigilance & Signal Management
Location: India (Remote | Hyderabad | Bengaluru)
Company: Parexel
Work Mode: Remote / Hybrid (India-based)
Compensation / Salary: Not disclosed (competitive as per industry standards)
Job Summary (Pharma / PV focused)
Parexel is hiring a Senior Medical Writer to lead signal detection, signal evaluation, and end‑to‑end safety medical writing across early and late-phase clinical development and post‑marketing portfolios. You will author SERs, validation reports, health authority responses, and provide strategic input on benefit–risk assessments, regulatory submissions, and risk management—ensuring compliance with ICH-GVP, FDA, EMA, and global pharmacovigilance (PV) expectations.
Key Responsibilities
Lead signal detection, tracking, assessment, and documentation (qualitative & quantitative) from multiple data sources (regulatory databases, sponsor DBs, literature, HA sites).
Author and review Signal Evaluation Reports (SERs), validation reports, HA responses, and other safety documents.
Provide safety input to new drug applications, regulatory filings, and benefit–risk assessments.
Maintain expert knowledge of product safety profiles, labeling, SOPs, and global PV regulations.
Support clinical narratives and cross-functional safety deliverables.
Conduct and deliver internal safety trainings; mentor junior team members.
Ensure compliance with global reporting timelines and inspection readiness.
Required Skills & Qualifications
Degree in Life Sciences / Health / Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, etc.).
Degrees in Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing with hospital exposure are an advantage.
Relevant experience in Medical Writing / Pharmacovigilance / Regulatory (Senior level role – preferably 4–6+ years).
Hands-on expertise with:
Signal detection & management (end-to-end)
SERs, PSUR/PBRER, RMPs, HA responses
Benefit–risk evaluation & safety surveillance
Strong command of ICH, GVP, FDA/EMA guidance.
Excellent analytical, writing, QC, and stakeholder communication skills.
Advanced MS Office & ability to work with web-based PV tools and databases.
Nice-to-Have (Boosters)
Experience with post-marketing safety & regulatory inspections.
Prior authorship of narratives, DSURs, PADERs, PSURs, PBRERs.
Familiarity with epidemiology, real-world data, and safety analytics.
Perks & Benefits
Competitive salary & performance benefits (undisclosed in JD).
Flexible / remote work options within India.
Learning & development, mentoring, career ladder progression.
Global, multicultural safety & medical writing teams.
Company Snapshot
Parexel is a leading global CRO (Contract Research Organization) delivering end-to-end clinical research, pharmacovigilance, regulatory, and safety medical writing services. With a strong focus on patient safety, GxP compliance, and global submissions, Parexel partners with top biopharma companies to accelerate development and ensure robust post‑marketing surveillance.
Work Mode
Remote / Hybrid – India (roles also listed for Hyderabad & Bengaluru).
Call to Action
Ready to advance your pharmacovigilance and safety writing career with a global leader? Apply now and help shape safety strategy, signal management, and regulatory excellence at Parexel.
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