If you’re looking to build a strong career in pharmacovigilance and regulatory medical writing, this opportunity is for you. Fidelity Health Services is actively hiring for the role of Executive Medical Writer (Safety / PV Writer) with expertise in RMP, PSUR, PBRER, and ACO preparation for EU, UK, and ROW regulatory submissions.

This is an excellent career move for candidates with 1–2 years of medical writing experience, especially those aiming to work with global safety reporting formats and GVP guidelines.

🔍 Job Overview

• Position: Executive Medical Writer (RMP / PSUR / PBRER Drafter)
• Job Code: FHS/2025/INS/25
• Location: Andheri (East), Mumbai – Onsite
• Experience Required: 01–02 years
• Employment Type: Full-time
• Joining: Immediate joiners preferred

🧪 Key Responsibilities

As an Executive Safety Writer, you will:

• Draft RMP, PSUR, PBRER, and ACO for Europe, UK & ROW markets including Ukraine, South Africa, Kazakhstan, etc.
• Generate Line Listings (LL) from the safety database.
• Coordinate with sales, regulatory, medical, and PV teams for safety-relevant data.
• Conduct literature searches aligned to pharmacovigilance compliance.
• Ensure safety documents meet regulatory expectations and timelines.
• Manage internal Quality Review (QR) and Medical Review (MR) cycles.
• Support audits, inspections, and SOP updates.
• Respond to regulatory authority queries related to submitted reports.

🎓 Required Qualifications

• Education: M.Pharm
• Experience: Minimum 1–2 years in safety medical writing / regulatory safety reports.

🧠 Skills & Competencies (Preferred)

• Working knowledge of PSUR, RMP, GVP Modules, MHRA regulations
• Strong command over MS Office: Word, Excel, PowerPoint
• Excellent communication and documentation skills
• Familiarity with safety databases or safety data extraction tools

⭐ Why Join Fidelity Health Services?

• Opportunity to work on global regulatory deliverables
• Exposure to multiple regulatory markets and compliance environments
• Skill growth in pharmacovigilance writing, regulatory strategy, and audit preparedness
• Work alongside a collaborative and experienced team

📨 How to Apply

Send your updated CV to:

📧 hrrecruitment@fidelityhs.com
💡 Mention the Job Code in the Subject Line: FHS/2025/INS/25