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...

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...

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

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...

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...

Job Description- Manage the set-up, planning, and maintenance of clinical studies in the client Portal- Maintain a strong understanding of client conventions or client specific database conventions, as appropriate- Begin participating in the generation of monthly status and other project-specific reports ensuring the quality and accuracy of metrics and data...

Role : Business Analyst.Job Location : Pune MumbaiNotice period : Imm to 30 daysMandatory Skills Description:• Overall 4 to 6+ years of experience out of which at least 2 years in OTC derivatives space• Must have minimum 3 years of experience in Business Analyst role.• Must have the extensive knowledge of derivatives• Must have general Business...