Veeda Lifesciences is a leading global provider of comprehensive drug development services. With a commitment to excellence and innovation in the pharmaceutical industry, we focus on providing high-quality solutions to meet the evolving needs of our clients. At Veeda, we believe in fostering a collaborative and inclusive work culture where every employee contributes to shaping the future of life sciences. We are now expanding our team to include passionate individuals in the field of pharmacovigilance.
Job Description
As a Pharmacovigilance Associate at Veeda Lifesciences, you will play a crucial role in ensuring the safety and efficacy of pharmaceutical products. Your responsibilities will involve the preparation of aggregate reports, managing literature searches, and case processing while maintaining compliance with regulatory guidelines.
Key Responsibilities
- Aggregate Reports:
- Collect safety data and prepare essential documents, including Risk Management Plans (RMPs), PBRERs/PSURs, PADERs, and addendums to clinical overview summaries.
- Collaborate with cross-functional teams to resolve issues during safety data review and report preparation.
- Ensure timely submission of reports to comply with regulatory standards.
- Literature Search & Review:
- Establish and monitor literature databases for relevant safety information.
- Conduct initial reviews of literature articles, classifying them into Individual Case Safety Reports (ICSRs), Adverse Outcomes of Interest (AOIs), and other relevant categories.
- Triaging & Case Processing:
- Receive, track, and triage ICSR submissions.
- Conduct duplicate searches to verify case information and ensure processing aligns with Standard Operating Procedures (SOPs).
- Perform quality reviews of cases against source documents.
- Medical Inquiry Management:
- Manage activities related to the Medical Information Contact Center (MICC).
- Respond to inquiries related to medical, pharmaceutical, and technical aspects, including reporting of adverse events (AEs).
- Maintain accurate records and ensure prompt responses to inquiries.
Required Skills
- In-depth knowledge of pharmacovigilance principles and regulatory guidelines.
- Familiarity with safety databases and literature search tools.
- Strong analytical and problem-solving capabilities.
- Excellent communication and documentation skills.
How to Apply
If you are passionate about pharmacovigilance and seeking a rewarding career with significant growth potential, we invite you to apply for the Pharmacovigilance Associate position at Veeda Lifesciences. Interested candidates can send their resumes to Vaibhav.D3662@veedalifesciences.com. 6359600877
