PrimeVigilance, a globally recognized leader in pharmacovigilance and regulatory affairs, is hiring Pharmacovigilance Medical Writer II professionals in Pune, Maharashtra, India.
This is your chance to join a rapidly growing CRO that partners with top global pharmaceutical and biotech companies—helping ensure patient safety through high-quality scientific writing and pharmacovigilance documentation.
🧠 About PrimeVigilance
Founded in 2008 and part of the Ergomed Group, PrimeVigilance provides expert pharmacovigilance, regulatory, and medical information services across the world. With a strong presence in Europe, North America, and Asia, the company values innovation, employee well-being, and continuous professional development.
🩺 Key Responsibilities
As a Pharmacovigilance Medical Writer II, you will:
- Prepare and review PSURs, PBRERs, PADERs, DSURs, ACOs, and RMPs.
- Perform QC and peer review of aggregate reports and PV documentation.
- Support project managers in report scheduling and deliverables.
- Identify and implement process improvements and contribute to SOP/template updates.
- Participate in client kick-off meetings, audits, and inspections.
- Provide training and mentoring to Associate Medical Writers.
🎓 Required Qualifications
- MD, Pharmacy, or Life Sciences degree (Master’s or PhD preferred).
- Strong experience in pharmacovigilance (case processing, signal detection, or risk management).
- Previous exposure in a CRO or pharmaceutical environment.
- Excellent command of English (written and spoken); other languages are an advantage.
- Ability to handle multiple projects with accuracy and timeliness.
- Team-oriented mindset with mentoring capability.
💼 Why Join PrimeVigilance?
PrimeVigilance offers a dynamic and supportive workplace that emphasizes diversity, personal growth, and career advancement.
Benefits include:
- Structured training and career development programs.
- Exposure to global pharmacovigilance projects.
- Inclusive, human-first company culture.
- Opportunity to work with international colleagues in an English-speaking environment.
📝 How to Apply
