Are you an experienced Medical Writer with expertise in signal detection, aggregate reports (PSUR/PBRER), PADER, and Risk Management Plans (RMP)? OrciMed Life Sciences is hiring! If you have at least 2 years of experience in pharmacovigilance and regulatory writing, this could be your next big opportunity.
Job Description: Medical Writer
Key Responsibilities:
- Prepare and review Periodic Safety Update Reports (PSUR/PBRER), Periodic Adverse Drug Experience Reports (PADER), and Risk Management Plans (RMP).
- Conduct signal detection and evaluation for pharmacovigilance.
- Develop high-quality aggregate reports and regulatory documents.
- Ensure compliance with ICH, GVP, and FDA/EMA guidelines.
- Collaborate with cross-functional teams to deliver accurate and timely reports.
Qualifications & Experience:
- Bachelor’s/Master’s/PhD in Life Sciences, Pharmacy, Medicine, or related fields.
- Minimum 2 years of experience in medical writing, specifically in PSUR/PBRER, PADER, and RMP.
- Strong understanding of pharmacovigilance regulations and safety reporting.
- Excellent scientific writing, editing, and communication skills.
- Proficiency in Microsoft Office, PubMed, and regulatory databases.
About OrciMed Life Sciences
OrciMed Life Sciences is a leading name in the pharmaceutical and life sciences industry, specializing in regulatory writing, pharmacovigilance, and medical communications. With a commitment to excellence, we provide high-quality scientific and regulatory solutions to global clients.
How to Apply?
If you meet the qualifications and are ready to take on this exciting role, email your updated resume to:
📧 careers@orcimedlifesciences.com
