Are you seeking a challenging and fulfilling career in pharmacovigilance? Veeda Clinical Research, a distinguished name in the pharmaceutical industry, is currently hiring a Case Processing / Aggregate Report Writer for our Ahmedabad office. This is an excellent opportunity for individuals with 4-6 years of experience in the field, offering a competitive salary ranging from 7 to 10 Lacs P.A. with a hybrid work model.
Job Overview
As a Case Processing / Aggregate Report Writer, you will play a crucial role in ensuring the safety and efficacy of pharmaceutical products through the preparation of aggregate safety reports and management of adverse event data. Your responsibilities will include the collection and analysis of safety data, preparing Risk Management Plans (RMPs), and compiling essential documents such as PSURs and PADERs.
Key Responsibilities
1. Aggregate Reports
- Collect and analyze safety data while preparing Risk Management Plans (RMP), PBRERs, PSURs, and PADERs in compliance with internal SOPs and regulatory guidelines.
- Collaborate effectively with cross-functional teams to address any issues during the preparation of aggregate reports.
- Ensure timely submission of reports to maintain 100% regulatory compliance.
2. Literature Search & Review
- Set up accounts and search strategies on relevant literature databases for effective data gathering.
- Conduct thorough reviews of literature articles, safety data exchange reports, and local literature, categorizing findings appropriately.
3. Triaging & Case Processing, Quality Check
- Manage case receipt and tracking, including triaging Incoming Case Safety Reports (ICSRs) and performing duplicate searches.
- Review the quality of ICSRs against source documents, ensuring processes adhere to SOPs.
4. Medical Enquiries
- Handle various medical, pharmaceutical, and technical inquiries, particularly those related to adverse events (AE).
- Ensure prompt responses to enquiries and documentation of all received inquiries for compliance purposes.
5. Submission of ICSR
- Verify cases for expedited reporting and ensure compliance with regulatory authorities’ requirements.
- Execute electronic and non-electronic reporting of ICSRs as outlined in SOPs.
6. Additional Responsibilities
- Assist in preparing for internal or external audits and maintain up-to-date knowledge of Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and relevant regulations.
- Support the Quality-PV and Medical Safety teams with the development and maintenance of key documents.
- Deliver training to new team members, ensuring they understand all protocols and processes related to pharmacovigilance.
Qualifications
- A Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field.
- 4-6 years of relevant experience in pharmacovigilance, case processing, or aggregate report writing.
- Strong understanding of GCP, GVP, and applicable regulatory guidance.
- Excellent communication and organizational skills, with the ability to work collaboratively in a team environment.
Why Veeda CR?
Joining Veeda CR means becoming part of a forward-thinking organization committed to improving patient safety and product efficacy. We offer a dynamic work culture that encourages professional growth, continuous learning, and teamwork. With our hybrid work model, you can enjoy the flexibility of working from home while also engaging with your colleagues in-office.
