About Fidelity Health Services :
Fidelity Health Services will be the recognized leader in Pharmacovigilance and clinical research, setting the standard for safety reporting, customer service, and team member satisfaction. They aspire to be the first choice of pharmaceutical companies for their Pharmacovigilance needs. They are committed to being a customer-focused organization whose work environment is characterized by quality, integrity & ethics, respect, teamwork, and accountability.
The company’s mission is to create and provide innovative Pharmacovigilance and clinical research solutions for top global pharmaceutical companies. Working in partnership with them, they would strive to provide exceptional safety reporting and customer satisfaction. As a partner of a pharmaceutical company in ensuring patient safety, Fidelity Health Services (FHS) offers proven Pharmacovigilance Services for comprehensive coverage of safety operation needs. It creates a centralized pool of Pharmacovigilance inputs to improve patient safety and regulatory compliance, achieve operational savings, and minimize litigation costs.
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About Fidelity Health Services Vacancy Details:
Company Name | Fidelity Health Services |
Designation | Aggregate Report Writer/ Safety Writer |
Qualification | M. Pharm / B. Pharm / BAMS / BHMS |
Experience | 3 to 4 years in preparation of aggregate reports and case processing. |
Location | Work From Home |
Job Profile | – Preparing and maintaining the aggregate report planner to keep a track of the global aggregate report submission. – Review various formats of aggregate reports like periodic adverse drug experience reports (PADER), Periodic safety update reports (PSUR), and Periodic Benefit Evaluation Reports (PBRER). – Collating data from various sources and having in-depth knowledge of the safety database. – Liaise with cross-functional teams to ensure all the required data are in place for the aggregate reports. – Preparing and maintaining the aggregate report compliance tracker and ensuring compliance and ensuring appropriate corrective and preventive actions are in place for deviations if any. |
Contact Email | Interested candidates can share CV at hr@fidelityhs.com |