Spec I Pss

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...

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. Conducting operations in...

Labcorp Drug Development As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired...

Qualification: Bachelors/Masters/PhD degree in Medicine or Alternative medicine or Pharmaceutical science or Sciences  5 plus years of overall work experience in the functional area with at least 2 years in Peer review/Quality review of any of the reports for global regulatory submissions and some experience in CAPAs and trending.  Experience in...

Ensuring that the IST investigator is providing study updates 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. - Regular follow up with the customer POCs for updates on the...

Labcorp Drug Development As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired...

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 **Labcorp is proud to be an Equal Opportunity Employer**: As an EOE/AA employer, Labcorp...

**Summary of Responsibilities**: - ** 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...

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 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...