Are you a skilled Pharmacovigilance professional looking for an exciting career opportunity in Hyderabad? Medifodil Smart Pharma Solution is hiring a Pharmacovigilance Specialist for its Drug Safety team in Kukatpally, Hyderabad. With over three years of experience in literature screening and case processing, you could join a dynamic team driving innovation in clinical research and drug safety. This on-site role offers a chance to work with cutting-edge safety databases and contribute to global healthcare solutions. Apply now to be part of Medifodil’s mission to accelerate drug development!
Key Responsibilities
As a Pharmacovigilance Specialist at Medifodil, you will play a critical role in ensuring drug safety and regulatory compliance. Your responsibilities will include:
- Conducting systematic literature surveillance using databases like Embase, PubMed, and Medline to identify relevant safety data.
- Screening and assessing articles for Individual Case Safety Reports (ICSRs) and other pharmacovigilance data.
- Performing end-to-end case processing for literature, spontaneous, and clinical trial reports.
- Utilizing safety databases such as Argus, PV Edge, Clinevo, ARISg, and Veeva Vault Safety for accurate data management.
- Ensuring compliance with global regulatory standards, including FDA, EMA, MHRA, ICH, and GVP.
- Collaborating with cross-functional teams to prepare safety reports like PADER, PSUR, and DSUR.
- Mentoring and training junior team members to uphold quality and audit-readiness.
Qualifications and Skills
To excel in this role, candidates must meet the following requirements:
- 3+ years of hands-on pharmacovigilance experience in literature screening and case processing.
- Strong knowledge of global regulatory guidelines (FDA, EMA, MHRA, ICH, GVP).
- Proficiency in coding, narrative writing, and seriousness/causality assessment.
- Familiarity with SmPC, USPI, and pharmacovigilance regulations.
- Experience with safety databases like Argus, PV Edge, Clinevo, ARISg, or Veeva Vault Safety.
- Commitment to quality, accuracy, and audit-readiness.
- Excellent communication and teamwork skills.
Why Join Medifodil?
Medifodil Smart Pharma Solution is a leader in clinical research, regulatory affairs, and medical writing, dedicated to delivering innovative healthcare solutions. By joining our team, you’ll enjoy:
- A collaborative and innovative work environment in Hyderabad.
- Opportunities to work on global projects with leading pharmaceutical clients.
- Professional growth through mentorship and training programs.
- A chance to contribute to drug safety and improve patient outcomes worldwide.
How to Apply
Ready to take the next step in your pharmacovigilance career? Submit your resume and cover letter to careers@medifodil.com
