
Spec I Pss
3 days ago
Ensuring that the IST investigator is providing study updates in tool as applicable to the customer viz. regulatory updates, enrolment data, confirming that safety information is being transferred to customer as required, notification of any amendments to either the protocol or informed consent.
- Reviewing that the agreed upon contractual milestones are being met and raising to customer for any threats to the milestones or if any milestones are missed.
- Monitoring eTMF compliance based on the eTMF filing plan and providing guidance to the Investigator site staff via raised queries in the communication portal
- Based on the Investigators enrolment plan, validate the initial drug supply demand and provide forecasting updates to customer as required
- Support presentations for customer governance calls.
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Assistant Ii Pss
3 days ago
Pune, India Labcorp Full timeAssist in the processing of expedited safety reports (ESRs). This includes, but is not limited to: - maintenance of adverse event tracking systems - set-up and maintenance of project files, core process files and central safety files - reporting of ESRs to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if...
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Spec I Pss
3 days ago
Pune, India Labcorp Full timeMaster’s degree in Pharmacy/related science area - Bachelor’s degree in Medical Science At least 3 years of experience in the pharmaceutical industry, with at least 2 years of it in medical writing - Efficiency in conducting literature searches for authoring various types of reports - Write various safety reports (or part of such reports) for global...
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Spec I Pss
3 days ago
Pune, India Labcorp Full timeEnsuring that the IST investigator is providing study updates in tool as applicable to the customer viz. regulatory updates, enrolment data, confirming that safety information is being transferred to customer as required, notification of any amendments to either the protocol or informed consent. - Reviewing that the agreed upon contractual milestones are...
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Spec Ii Pss
4 days ago
Pune, India Labcorp Full timeImplement consistent, efficient and quality processes to meet timelines and deliverables according to requirements and standard operating procedures Ensure compliance of operations with governing regulatory requirements Create, maintain and assume accountability for a culture of high customer service Execute drug safety data management processes - a...
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Spec Ii Pss
3 days ago
Pune, India Labcorp Full timeMaster’s degree in Pharmacy/related science area - Bachelor’s degree in Medical Science - At least 5 years’ experience in the pharmaceutical industry, with at least 3 years of it in medical writing - Experience in drug discovery and pharmacovigilance is desirable - Write various safety reports (or part of such reports) for global regulatory submissions...
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Spec Ii Pss
22 hours ago
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Safety Science Coordinator I
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