Here’s a refined version of the Pharmacovigilance job description for the position located in Chandigarh:
Position: Pharmacovigilance Associate
Location: Chandigarh, India
Department: Pharmacovigilance
Company: [Company Name]
The Pharmacovigilance Associate will be responsible for managing activities related to the processing, follow-up, analysis, and regulatory reporting of adverse events (AEs) and serious adverse events (SAEs) for both marketed and investigational human and veterinary products. The role ensures compliance with regulatory requirements and supports the preparation of aggregate safety reports, including Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), and similar documents.
Adverse Event Management:
Process, analyze, and report AEs and SAEs for marketed and investigational products in accordance with applicable regulatory requirements.
Aggregate Report Preparation:
Prepare aggregate reports, such as PBRERs, PSURs, Addendum PSURs, PSUR Line Listings, and US PADERs, based on data collected for products. Ensure these reports are in line with client conventions and regulatory guidelines.
Quality Checks:
Perform quality checks on aggregate reports, ensuring the accuracy and completeness of the data before submission.
Signal Detection & Analysis:
Conduct signal detection activities and perform analyses related to cumulative data and issue event identification. Prepare reports based on findings.
Regulatory Compliance:
Ensure all pharmacovigilance activities comply with the applicable national and international regulatory requirements.
Data Evaluation:
Analyze data and draw conclusions independently, providing concise and accurate summaries of medical text and data.
Education:
Skills & Competencies:
Why Join Us?
At [Company Name], we offer a dynamic working environment where you can grow your career in the growing field of pharmacovigilance. Join our team and make an impact in improving patient safety globally.
For more information and to apply, visit: [Company Careers Page or Job Application Link]
This description provides a comprehensive overview of the role while highlighting the essential qualifications and responsibilities. Let me know if you'd like further adjustments!
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