Spec Ii Pss

Assist 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...

Job Overview:Assist with the overall Clinical Safety and/or PSS operations associated with products including the entire adverse events process: which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to the...

Manage the receipt and processing of all adverse event reports reported either spontaneously from any source or from a clinical trial. This includes, but is not limited to: - entry of safety data onto adverse event database(s) and tracking systems - review of adverse events for completeness, accuracy and appropriateness for expedited reporting - write...

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...

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...

Master’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...

Execute drug safety data management processes - a combination of call intake, case intake, triage, case entry, medical coding, narrative writing, peer review, case follow - up. Perform any other support activities as assigned - tracking various types of information and metrics, ongoing QC of defined process steps, training, reconciliation of data from...

Implement 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 Operational - Execute drug safety data management...

**Job Overview**: Assist with the overall Clinical Safety and/or PSS operations associated with products including the adverse events process which may include safety data collected from clinical trials and/or post marketing setting (i.e., unsolicited reports). Manage and process expendable adverse events to the required standard and submit them to the...

Our PurposeMastercard powers economies and empowers people in 200+ countries and territories worldwide. Together with our customers, we're helping build a sustainable economy where everyone can prosper. We support a wide range of digital payments choices, making transactions secure, simple, smart and accessible. Our technology and innovation, partnerships...