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...

Data entry of safety data onto adverse event tracking systems - Write patient narratives & code adverse events accurately using MedDRA (for Marketed products, if applicable) - Assist in the listedness assessment against appropriate label (for Marketed products, if applicable) - Generate queries for its collection of missing or discrepant information in...

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 Execute drug safety data management processes - a...

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...

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...

**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...

Ensuring that the IST investigator is providing study updates in a client 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...

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...