Clinical Safety Scientist - Lead Golden Opportunities

3.0 - 7.0 years

0 Lacs

hyderabad, telangana

On-site

Role Overview: You will be responsible for conducting literature review to assess ICSR and new safety signals for inclusion in Aggregate report and Drug Safety reports. Additionally, you will provide MAH comments for selected literature and review Literature Strategy. Your role will also involve designing and interpreting various types of studies in medicine for safety analyses and ensuring scientific accuracy of outputs triaged by safety scientists. You will be authoring Safety Sections of SSSRs, DSUR, aCO & PBRER, as well as RMP updates & implementation plans. Reviewing various types of listings for Signal Detection will also be a part of your responsibilities. Key Responsibilities: - Cond...

Posted 1 week ago

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Clinical Safety Scientist - Lead Golden Opportunities

3.0 - 7.0 years

0 Lacs

hyderabad, telangana

On-site

Role Overview: As a Clinical Safety Scientist - Lead, your primary responsibility will be to conduct literature reviews to assess ICSR and new safety signals for inclusion in Aggregate reports and DSR (Drug Safety reports). You will also provide MAH comments for selected literature and review Literature Strategy. Additionally, you will be involved in designing and interpreting various types of studies in medicine, assessing levels of evidence, study power for safety analyses, and reviewing outputs triaged by safety scientists for scientific accuracy based on specific criteria. Moreover, you will be responsible for authoring Safety Sections of SSSRs, DSUR, aCO, PBRER, RMP updates, and impleme...

Posted 2 months ago

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Pharmacovigilance Aggregate Reporting : Life Sciences : Apply Now Outpace Consulting Services

3.0 - 8.0 years

10 - 15 Lacs

Pune, Mumbai (All Areas)

Work from Office

Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines Job Responsibility Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform ...

Posted 6 months ago

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Life Sciences : Pharmacovigilance Aggregate Reporting : Apply Now Outpace Consulting Services

3 - 8 years

10 - 15 Lacs

Pune, Mumbai (All Areas)

Work from Office

Posted 7 months ago

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Aggregate Safety Report : Life Science : Max 15 LPA : Apply Outpace Consulting Services

3 - 8 years

10 - 15 Lacs

Pune, Mumbai (All Areas)

Work from Office

Posted 7 months ago

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