Urgent Hiring for PSUR Writing Role @ Indegene

Home > Hospital Management / Director

Urgent Hiring for PSUR Writing Role

Indegene
3 to 6 Yrs
Bengaluru
3 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 time
Industry: Medical / Healthcare
Role Category: Hospital Management / Director
Functional Area: Not Applicable
Role/Responsibilies: Urgent Hiring for PSUR Writing Role

Contact Details:

Company: Indegene
Location(s): Bengaluru

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Preferred City (* max. 2 w/comma)

Designation / Expected Role

Current / Recent Company (*)

Experience (*)

Expected Salary (*)

Desired Industry (*):

Functional area / Department (*):

Enter Skills (key skills, subjects, technologies & roles to use in search)

Write briefly about yourself, your experience and education (*)

Attach ResumeMax 2.38 MB (RTF, PDF, DOC, DOCX formats only parsed)

Please, check the file size and type.

Add social media [ + ]

Create password

I agree with website service terms and conditions

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 worldâ€™s Top 25 pharma companies, help...

Urgent Hiring for PSUR Writing Role @ Indegene

Home > Hospital Management / Director