Are you an experienced pharmacovigilance professional looking to advance your career in quality assurance? Pharmazone, a leading name in pharmaceutical services since 2009, is hiring for a Pharmacovigilance Quality Assurance (QA) role in Ahmedabad. With a team of over 100 dedicated professionals and accolades like the Best Healthcare Brand in Gujarat by CMO Asia, Pharmazone offers a dynamic environment to ensure drug safety and compliance with global standards. This is your chance to join a company recognized among the top 10 clinical research service providers by Silicon India in 2018.
This Pharmacovigilance QA job in Ahmedabad is ideal for candidates with 6-10 years of experience and a strong understanding of global PV regulations and GVP guidelines. Read on to explore the responsibilities, qualifications, benefits, and how to apply for this exciting opportunity in 2025.
Job Responsibilities
As a Pharmacovigilance QA professional at Pharmazone, you will play a critical role in ensuring compliance and quality in pharmacovigilance processes. Your key responsibilities include:
- Conducting quality checks on Individual Case Safety Reports (ICSRs) to ensure accuracy and regulatory compliance.
- Reviewing and assessing medical information for adherence to global pharmacovigilance regulations.
- Developing and implementing consistent processes to produce Key Performance Indicators (KPIs).
- Collaborating with cross-functional teams to maintain and update safety databases.
- Assisting in the development and modification of quality documents and business processes.
- Providing training on pharmacovigilance QA practices and ensuring adherence to Good Vigilance Practices (GVP) guidelines.
- Coordinating and leading Safety Management Committee (SMC) meetings to ensure timely deliverables.
Qualifications and Skills
To excel in this Pharmacovigilance QA role, candidates must meet the following criteria:
- Education: B.Pharm or M.Pharm from a recognized institution.
- Experience: 6-10 years of core experience in Pharmacovigilance Quality Assurance (PV-QA).
- Knowledge: In-depth understanding of global pharmacovigilance regulations (e.g., FDA, EMA, ICH-GCP) and GVP guidelines.
- Skills:
- Strong analytical and problem-solving abilities.
- Proficiency in Microsoft Excel, Word, PowerPoint, and technical writing.
- Familiarity with signal detection tools and processes (e.g., FAERS, WHO-Vigibase).
- Experience with LEAN methodology and business process implementation.
- Excellent communication and team collaboration skills.
- Preferred: Clinical experience and consulting background are a plus.
Benefits of Joining Pharmazone
Pharmazone is committed to fostering a rewarding work environment for its employees. By joining the team, you can expect:
- Career Growth: Opportunities to work with a leader in pharmaceutical services, contributing to innovative drug safety solutions.
- Professional Development: Access to training programs to enhance your expertise in pharmacovigilance and QA practices.
- Collaborative Culture: Work with a dedicated team of over 100 professionals in a supportive and inclusive environment.
- Recognition: Be part of a company honored with prestigious awards for excellence in clinical research and healthcare.
How to Apply
Ready to take the next step in your pharmacovigilance career? Follow these steps to apply for the Pharmacovigilance QA position (Vacancy Code: PZQMS003):
- Prepare your updated resume, highlighting your PV-QA experience and qualifications.
- Send your resume to hr@pharmazones.com, mentioning the vacancy code PZQMS003 in the subject line.
- For inquiries, contact Pharmazone at +91 9898778211.
