Bio Medical jobs in Chennai, Tamil Nadu

Job Summary

Pharmnova Medical Research is seeking a detail-oriented and motivated Medical Writer – Pharmacovigilance & Drug Safety to join our growing team. The successful candidate will be responsible for preparing, reviewing, and maintaining high-quality pharmacovigilance and drug safety documents while ensuring compliance with global regulatory requirements and industry standards.

This role offers an excellent opportunity to work on global safety projects, contribute to patient safety initiatives, and gain exposure to a broad range of pharmacovigilance, risk management, and regulatory documentation activities.

Key Responsibilities

Prepare, review, and maintain pharmacovigilance and drug safety documents in accordance with applicable regulatory requirements and company procedures.

Author and contribute to aggregate safety reports, including:

• Periodic Safety Update Reports (PSURs)
• Periodic Benefit-Risk Evaluation Reports (PBRERs)
• Development Safety Update Reports (DSURs)
• Risk Management Plans (RMPs)
• Safety narratives
• Clinical and safety summaries
• Conduct medical and scientific literature reviews to support safety evaluations and regulatory submissions.
• Analyze and summarize clinical and safety data from multiple sources.
• Support signal detection, risk management, benefit-risk evaluation, and safety surveillance activities.
• Collaborate with Pharmacovigilance, Regulatory Affairs, Clinical Operations, Medical Affairs, Quality, and other cross-functional teams.
• Ensure consistency, accuracy, scientific integrity, and quality of all safety documentation.
• Maintain document templates, version control, and document management records.
• Support responses to client, regulatory authority, and internal safety documentation requests.
• Assist in the preparation of presentations, safety reports, and other scientific documents as required.
• Support audit and inspection readiness activities.

Qualifications

Bachelor's or Master's degree in Dentistry, Pharmacy, Nursing, Bio Sciences, or other relevant Healthcare and Life Sciences disciplines.

1- 4+ years of experience in Medical Writing, Pharmacovigilance, Drug Safety, Clinical Research, Regulatory Writing, Scientific Writing, or related healthcare fields.

Freshers with relevant pharmacovigilance training and strong scientific writing skills may also be considered.

Required Skills

Excellent scientific, medical, and technical writing skills.

Strong understanding of pharmacovigilance and drug safety principles.

Ability to interpret, analyze, and summarize medical and scientific information.

Strong attention to detail and commitment to quality.

Good analytical and critical-thinking abilities.

Excellent written and verbal communication skills.

Proficiency in Microsoft Office applications, including Word, Excel, and PowerPoint.

Ability to manage multiple assignments and meet project timelines.

Preferred Skills

Experience in preparing PSURs, PBRERs, DSURs, RMPs, safety narratives, and clinical safety summaries.

Knowledge of ICH, FDA, EMA, MHRA, and other global pharmacovigilance regulations and guidelines.

Familiarity with MedDRA terminology and pharmacovigilance databases.

Experience in literature surveillance, signal management, and safety data review.

Understanding of clinical development, regulatory affairs, and risk management processes.

Exposure to AI-enabled medical writing or safety analytics tools will be an advantage.

What We Offer

Opportunity to work on global pharmacovigilance and drug safety projects.

Exposure to international regulatory requirements and industry best practices.

Professional development and career growth opportunities.

Collaborative, supportive, and learning-focused work environment.

Opportunity to contribute to patient safety and healthcare innovation.

Pay: ₹300,000.00 - ₹800,000.00 per year

Education:

• Bachelor's (Preferred)

Experience:

• Medical Writing, Pharmacovigilance, Drug Safety,: 1 year (Required)

Work Location: In person