Neha Singh

About Neha Singh

Most pharmaceutical and biotech teams are not short of safety data.They are short of time, senior scientific bandwidth, and documentation that regulators find immediately clear and defensible.That is the gap Nirvexra Solutions was built to fill.I am Dr. Neha Singh, Co-Founder of Nirvexra Solutions — a PhD-qualified pharmacovigilance and regulatory writing specialist with over 11 years of experience across global pharma, biotech, and CRO environments.My work sits at the point where safety science meets regulatory obligation. Every aggregate report, benefit–risk evaluation, and evidence synthesis we deliver is scientifically sound and built to withstand scrutiny — not just submitted.I work with sponsor teams and CROs on: Aggregate safety reporting — PBRERs, DSURs, Addendum to Clinical Overview (ACOs), and ad-hoc benefit–risk assessments authored to ICH E2C standards and EMA/FDA expectations Benefit–risk documentation — structured evaluation frameworks and integrated safety summaries aligned to GVP Module V Literature-driven safety evaluation — signal contextualisation, evidence integration, and safety narrative development Evidence synthesis — systematic and targeted literature reviews aligned to PRISMA and Cochrane methodology, supporting regulatory submissions and HTA strategy ICSR narratives — medically accurate, regulator-ready documentation aligned to ICH E2B standardsTherapeutic areas: oncology, neurology, rare diseases, autoimmune disorders, infectious diseases, metabolic conditions, and women\'s health.At Nirvexra, both founders are named on every project.The person you scope the work with is the person who delivers it.That is not standard in this industry. That is the point.Cochrane Member · ISCR Lifetime MemberIf your team is approaching a PBRER or DSUR cycle, managing signal evaluation pressure, or building a long-term PV writing partnership — I\'d welcome a conversation. h••••@nirvexrasolutions.com

Experience

1. Co-founder

   Nirvexra Solutions

   Nov 2025 — Present · Chandigarh, IN

   Lead the delivery of pharmacovigilance, medical writing, and evidence synthesis solutions for global life-sciences teamsDevelop regulator-ready safety documentation, including DSURs, PSUR/PBRERs, RMPs, and benefit–risk narrativesEnsure clear, defensible scientific communication across clinical, regulatory, and payer-facing deliverablesEstablish scalable workflows, templates, and quality standards aligned with FDA and EMA expectationsPartner closely with CROs, consulting firms, medical communications agencies, and biopharma teams

Education

• Panjab University

  Master of Science - MS

• Panjab University

  Doctor of Philosophy - PhD