Pharma Professional Services has job openings for Pharmacovigilance Scientist. Jobs located in Edison, NJ. Review non-serious and serious AEs and aggregate AE listings. Prepare signaling meeting presentations in collaboration with the team, including a review of events of interest, initial trending of AEs, set thresholds for escalation, and preparation of meeting minutes. Monitor the safety profile of assigned compounds to identify any safety signals and support execution of plans for signal evaluation. Requires Bachelor’s degree or foreign equivalent in Computer Science, Engineering (any), Public Health, Biotechnology, Life Sciences, or related. Will also accept 2 years of experience in the job offered or as a related Science Professional in lieu of Bachelor’s degree.

Pharma Professional Services has job openings for Sr. Clinical Research Associate I. Jobs located in Edison, NJ and various unanticipated locations throughout the U.S. Identify and initiate appropriate investigational sites for clinical studies. Administer, coordinate, and monitor research projects according to guidelines and federal regulations. Maintain databases of critical patient information, draft correspondence, and gather data relevant to budgeting. Develop and write trial protocols. Travel to various unanticipated locations throughout the U.S. for long and short term assignments at client sites. Requires Master’s degree or foreign equivalent in Computer Science, Engineering (any), Business Administration, Life Sciences, or related

Pharma Professional Services, has job openings for Sr. Validation Engineer I. Jobs located in Edison, NJ and various unanticipated locations throughout the U.S. Analyze validation test data to determine whether systems or processes have met validation criteria and to identify root causes of problems for various pharma and other facilities. Prepare validation and performance qualification protocols for new or modified processes, systems, or equipment for various production types. Coordinate the implementation or scheduling of validation testing with affected departments and personnel. Create, populate, and maintain databases for tracking validation activities, test results, and validate systems. Travel/relocate to various unanticipated locations throughout the U.S. for long and short term assignments at client sites. Requires Master’s degree or foreign equivalent in Regulatory Affairs, Pharmaceutical Sciences, Pharmacy, Chemistry, Biochemistry, Biology, or a related life sciences discipline.

Pharma Professional Services, LLC has job openings for Drug Safety Associate.Jobs located in Edison, NJ and various unanticipated locations throughout the U.S.Receives clinical study SAE reports, review for medical/regulatory content and assure accuracy per protocol requirements, obtaining follow up as needed; ensure that all SAE’s are complete prior to database closure Process and distributes clinical study SAE reports as per the company SOPs Completes AE/SAE reconciliation prior to clinical trial database closure Receives, processes, and distributes spontaneous adverse event reports for marketed products, both serious and non-serious, as per the company’s SOP’s .Processes all types of adverse event reports utilizing the ARIS safety database Assists with preparing and/or reviewing safety summaries for Investigator Brochures and annual reports, safety submissions for marketed products, and other safety reports as needed or requested Assists with providing safety support and training for clinical, monitoring, and clinical site personnel as needed Assists with implementing safety surveillance processes and establishing appropriate SOPs Experience. Requires a minimum of a Bachelor’s Degree in Pharmaceutical Science or a related area and relevant 1-2 years of experience