OrciMed Life Sciences Hiring Medical Writers

Medical Writer Openings – 2+ Yrs Exp – OrciMed

OrciMed Life Sciences hiring Medical Writers with 2+ years experience in signal detection, PSUR/PBRER, PADER, RMP.

OrciMed Life Sciences is looking for experienced medical writing professionals to support safety reporting and regulatory documentation. This opening is ideal for candidates with hands-on experience in drug safety, signal detection and aggregate report writing for global regulatory submissions.

Company Overview

OrciMed Life Sciences provides specialised services in medical writing, pharmacovigilance, and safety documentation for pharmaceutical and biotech clients. The company focuses on delivering accurate, compliant, and scientifically robust safety reports aligned with global regulatory guidelines, including EMA, FDA, and ICH.

Job Role & Responsibilities

Medical Writer – Pharmacovigilance & Safety Reports

• Prepare high-quality aggregate safety reports including PSUR/PBRER, PADER, and RMP.
• Support signal management activities and prepare signal evaluation reports.
• Ensure accuracy and consistency in clinical safety narratives and regulatory submissions.
• Analyse safety data and integrate findings into structured sections of aggregate reports.
• Collaborate with safety physicians, PV operations, and quality reviewers.
• Ensure adherence to ICH, EMA, FDA and GVP Module guidelines.

Eligibility / Qualifications

• Minimum 2 years of experience in Pharmacovigilance Medical Writing.
• Strong exposure to PSUR/PBRER, PADER, RMP, and signal management.
• Proven ability to interpret safety data and write regulatory-compliant documents.
• Excellent written communication and understanding of safety databases.

Relevant Courses: B.Pharmacy, M.Pharmacy (Pharmaceutics/Pharmacology/Regulatory), Pharm.D, M.Sc Life Sciences, Clinical Research Certifications, PV Medical Writing Certification.

Location & Salary

• Location: As per company assignment (remote/on-site based on requirement)
• Salary: Competitive and based on experience

Application Process

Interested candidates can send their updated resume to:
Email: careers@orcimedlifesciences.com

Use subject line: Application – Medical Writer – Safety Reports

Summary Table