Urgent Hiring for PSUR Writing Role
- Indegene
- 3 to 6 Yrs
- Bengaluru
- 2 years ago
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Job Description
Greetings from Indegene !!
We are hiring for PSUR Writing role.
Interested candidates may send in their updated resume for the rounds of discussion.
HR - Nivedita - ni***********a@in*****e.com
Pls find below the JD :
Experience : 3-5 years
Immediate joiners only
Location :Bangalore
- Good communication and analytical skills.
- Knowledge of EU MDR 2017/745, Rev 4.0 guidelines
- Knowledge of overall PMS process for the Medical Devices
- Responsible for end-to-end creation of the PSUR
- Good understanding of Clinical trials, Adverse events, Serious Adverse Events, Adverse Device effects and Medical Device documents including CER, PSUR, PMS plan, IFU, PMCF plan/report, Risk Files and sales data tables.
- Basic understanding of definitions of therapeutic areas like Cardiovascular, Neurology, Respiratory, Renal, Gastroenterology etc.
- Literature articles analysis summarization of safety and performance field, extraction of AE data and identify device specific risks.
- Complaint data analysis to calculate occurrence rate of AEs.
- Knowledge to perform vigilance database search.
- Quality check (QC), Quality Assurance (QA), and Peer Review (PR) of deliverables.
- Attaching relevant emails and source documents in the share-folders.
- Well-versed with MS Office.
- Previous experience in PSURs, PBRERs, SUSARs is preferable.
Employement Category:
Employement Type: Full timeIndustry: Medical / Healthcare
Role Category: Hospital Management / Director
Functional Area: Not Applicable
Role/Responsibilies: Urgent Hiring for PSUR Writing Role
Contact Details:
Company: IndegeneLocation(s): Bengaluru
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Indegene
Indegene is a specialized healthcare solutions company with a unique blend of life sciences domain expertise and state-of-the-art technological capabilities. Headquartered in Bengaluru, with offices across the world, Indegene is a partner to most of the world’s Top 25 pharma companies, help...
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