📝 Pharmacovigilance Medical Writer II – PrimeVigilance, Pune
Published on October 10, 2025
📍 Location: Pune, Maharashtra, India
🎓 Eligibility: M.Pharm, M.Sc, Pharm.D, Ph.D, MD (Life Sciences / Pharmacy / Medicine)
🧪 Experience: 3 – 6 Years
💼 Job Type: Pharmacovigilance Medical Writer II | Full-Time | Medical Writing | PV | CRO
🔎 Verified: ✅ Verified Job
📄 Job Overview
PrimeVigilance, a globally recognized leader in pharmacovigilance and regulatory affairs (part of the Ergomed Group), is hiring for the role of Pharmacovigilance Medical Writer II at its Pune office. This role suits experienced PV/medical writing professionals who want to contribute to global safety reporting and regulatory documentation.
🧠 About PrimeVigilance
Founded in 2008 and part of the Ergomed Group, PrimeVigilance delivers expert pharmacovigilance, regulatory, and medical information services globally. The company emphasizes innovation, high-quality science, and professional growth.
🩺 Key Responsibilities
- ✔ Prepare and review aggregate safety reports: PSURs / PBRERs / PADERs / DSURs / ACOs / RMPs.
- ✔ Perform QC and peer review of aggregate reports and pharmacovigilance documentation.
- ✔ Support project managers in report scheduling and timely deliverables.
- ✔ Identify and implement process improvements; update SOPs and templates as needed.
- ✔ Participate in client kick-offs, audits, and inspections; provide responses as required.
- ✔ Provide training and mentoring to Associate Medical Writers.
✅ Required Qualifications & Skills
- ✅ MD, M.Pharm, M.Sc, Pharm.D, or Ph.D (preferred) in Life Sciences / Medicine / Pharmacy.
- ✅ 3–6 years' experience in pharmacovigilance, medical writing, or regulatory writing (CRO/pharma experience preferred).
- ✅ Strong understanding of PV processes, aggregate reporting, signal detection and risk management.
- ✅ Excellent written and spoken English; strong scientific writing skills.
- ✅ Ability to handle multiple projects with accuracy, meet deadlines, and work in cross-functional teams.
🎁 Why Join PrimeVigilance?
- 🌍 Exposure to international pharmacovigilance projects and global clients.
- 🧑🏫 Structured training, mentorship, and career development.
- 🤝 Inclusive and people-first culture with growth opportunities.
- 💼 Work with a strong PV & regulatory team within the Ergomed Group.
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📌 Note Before You Apply:
Update your CV to highlight aggregate report writing (PSUR/PBRER/DSUR), PV processes, signal detection, and regulatory experience to improve selection chances.
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🟢 Verified Job – PrimeVigilance (Ergomed Group)
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