Navatio Pharma is a dedicated player in the healthcare and pharmaceutical industry, committed to advancing public health through rigorous safety standards and innovative solutions. We foster a culture of excellence, collaboration, and continuous learning. Our team is comprised of passionate professionals working towards a common goal of ensuring drug safety and efficacy for patients worldwide. Joining Navatio Pharma means becoming part of a forward-thinking organization that values your expertise and invests in your professional development.
Job Description: Drug Safety Associate (Literature Reviewer)
As a Drug Safety Associate specializing in literature review, you will be a crucial member of our Pharmacovigilance team. Your primary responsibility will be to monitor and review global scientific and medical literature to identify individual case safety reports (ICSRs) and other relevant safety information. Your analytical skills will be key in maintaining the highest standards of drug safety.
Key Responsibilities:
- Conduct systematic screening of global literature databases (e.g., PubMed, EMBASE) for articles related to our products.
- Identify and extract individual case safety reports (ICSRs) and other significant safety information from scientific literature.
- Perform quality review of literature cases to ensure accuracy, consistency, and compliance with global regulations (like ICH-GCP) and company Standard Operating Procedures (SOPs).
- Assist in the preparation and submission of literature reports to regulatory authorities within stipulated timelines.
- Maintain comprehensive documentation for all literature screening activities.
- Collaborate effectively with the broader drug safety team on various pharmacovigilance activities.
Qualifications and Experience Required
To be successful in this Drug Safety Associate role, you should possess the following:
- A Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Pharmacology, or a related field.
- 2 to 5 years of relevant experience in a pharmacovigilance or drug safety department.
- Prior hands-on experience with literature review for ICSR identification is highly preferred.
- Strong analytical skills and impeccable attention to detail.
- Excellent written and verbal communication skills.
- The ability to work independently, manage time effectively, and adhere to strict deadlines.
How to Apply
If you are ready to take the next step in your pharmacovigilance career and meet the above qualifications, we would love to hear from you.
Please send your updated resume/CV to our HR department at: hr@navatiopharma.com
