Spec I 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...

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...

Assist in the processing of Expedited Safety Reports (ESRs), Periodic Safety Reports (PSRs) and submission, including but not limited to - Maintenance of adverse event tracking systems - Set-up and maintenance of project files, and central files for documentation - Assist with the reporting of ESRs & PSRs to clients, Regulatory Authorities, Ethics...

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...

**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 settings (i.e., unsolicited reports). Manage and process expeditable adverse events to the required standard and submit them to...

Master’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...

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 - To respond to medical information queries/product...

Job Summary: Responsible for Project E&I Engineering Design based on customer specifications, proposal BID in alignment with internal standards. Coordinate with Mechanical and Software functional teams for equalization of interrelated work. Flexibility to work according to priority and deadlines. Responsible for selection / sizing and ordering of all E&I...

**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...