14/01 Rajkamal
Senior Consultant at Golden Opportunities

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Pharmacovigilance/Drug Safety Role - Aggregate Reporting - Hospital - MD/MS (5-10 yrs)

Mumbai Job Code: 8841

Elite & Confidential Jobs - Pharmacovigilance/Drug Safety - Aggregate Reporting (PSUR/PBRER/PADER)


Job role:

Medical professional prepares & submits Aggregate reports (PSUR/PBRER/PADER/PAER), Risk Management Plan(RMP), handling medical queries and signal management.

Job Description:

- Draft and review of PBRERs with focus on medical aspects of the products and safety sections. Also, collecting and analysing various safety trends for the product.

- Draft and review of Risk Management Plans as per Regulatory requirement. Focus on the identification of risk and the categorization.

- Assist in identification, analysing and concluding safety data for any cumulative trends.

- Searching and analysing published scientific literature for resolution of queries

- Good knowledge of regulations in pharmacovigilance to assess the risk-benefit of a product and identify any gaps in the aggregate documents

Basic Qualifications:

- Should be qualified MBBS or MD/MS

- Should be MCI (Medical Council of India) Certified

- Should have 4+years of experience in Aggregate Reporting(PSUR/PBRER/PADER/PAER/DSUR), Risk Management and Signal Detection.

Other Information:

Work Location: Mumbai

Salary: Can be discussed

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