Are you a recent graduate with a degree in Pharmacy (B. Pharm/M. Pharm) and a passion for ensuring the safety of pharmaceutical products? Fortera, a leading name in the healthcare industry, is thrilled to announce openings for Pharmacovigilance Case Processors. If you’re eager to kick-start your career in pharmacovigilance and make a real difference in the pharmaceutical sector, we want to hear from you! At Fortera, we pride ourselves on fostering an inclusive and innovative work environment. As a Pharmacovigilance Case Processor, you will play a vital role in our commitment to drug safety and quality. Joining Fortera means being a part of a dynamic team where your skills are valued, and your career growth is nurtured.
Position Title: Pharmacovigilance-Case Processor (Fresher)
Education: B. Pharm/M. Pharm (Completed)
Key Skills:
1. Pharmacovigilance
2. Case Processing
3. Adverse Event Reporting
4. Data Entry
5. MedDRA
6. Regulatory Compliance
7. Safety Information
8. Clinical trials
9. Quality management
Job Description
As a Pharmacovigilance-Case Processor at Fortrea, you will play a critical role in ensuring the safety of pharmaceutical products and the well-being of patients. Your responsibilities will include, but are not limited to:
Case Intake and Triage: Receiving and assessing safety information or reports from various sources, including clinical trials.
Adverse Event Processing:
1. Data entry of safety data into adverse event tracking systems.
2. Writing patient narratives and accurately coding adverse events using MedDRA.
3. Assisting in the listedness assessment against appropriate labels for marketed products (if applicable).
4. Generating queries and collecting missing or discrepant information in consultation with medical staff.
5. Submission of expedited Serious Adverse Event (SAE) reports to clients, regulatory authorities, ethics committees, investigators, 3rd party vendors, partners, and Fortrea project personnel as required, within agreed timelines.
Regulatory Compliance: Processing and submitting expedited and periodic reports to worldwide regulatory agencies or other recipients, ensuring compliance with regulatory timelines.
Database Reconciliation: Assisting in the reconciliation of databases as required.
Quality Management: Working within the Quality Management System framework, including Standard Operating Procedures (SOP) and departmental Work Instructions (WIs).
Documentation: Maintaining supporting files/documentation regarding adverse event reporting requirements in all countries (if applicable).
Supporting the upload/archival of case/study/project documentation.
Collaboration: Building and maintaining good relationships across functional units to ensure effective communication and cooperation.
Compliance: Supporting compliance with governing regulatory requirements and other responsibilities as assigned by management.
Employment Type: Full-Time (6-month contract)
Role Category: Pharmacovigilance
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