Fidelity Health Services are frontline adopters in technology-based solutions for our clients. By combining high-end Technologies with skilled human resources & smart processes, our pharmaceuticals, biopharma & life sciences clients are effectively advancing discoveries, and are delivering solutions that make a difference in patients’ lives.
Post : Aggregate report Writer / Safety Writer
Qualification : M.Pharm / B.Pharm / BAMS / BHMS
Experience : Minimum 3-4 years of experience in preparation of aggregate reports and case processing.
Location : Mumbai
Job Description
• 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 Report (PADER), Periodic Safety Update Report (PSUR), Periodic Benefit Evaluation Report (PBRER)
• Collating data from various sources and having in-depth knowledge of the safety database.
• Liase 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.
Interested candidates can share CV on hr@fidelityhs.com
Last Date : 20th July, 2023
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