Pharmanet Work Values

Daily Duties at Pharmanet:

• Monitored clinical trial studies, including site selection and initiation, interim monitoring, final closeout and drug closeout visits for multiple sponsors in therapeutic areas of virology, immunology, dermatology, cardiovascular events central nervous system and metabolic. • Completed monitoring of 15 sites on a Phase IIIB randomized double-blind clinical trial for Bristol Myers Squibb diabetes drug. • Designed monitoring conventions for a Takeda diabetes clinical trial. • Created study team tools for and monitored clinical trial of ankylosing spondylitis, contributing to Embrel receiving its related NDA. • Ensured adherence to protocol during monitoring visits, including: reporting violations to sponsors and resolving them in collaboration with medical monitor; and resolving case report form (CRF) discrepancies and other issues. • Performed drug accountability, return, and destruction, as well as regulatory binder audit. • Served as independent drug auditor for dermatology study cardiovascular study and ophthalmology. • Presented CRF’s at investigator meeting for ankylosing spondylitis.

What they like about Pharmanet:

Working in an organization that is technologically advanced, creative, and innovative is critical in your assessment of hiring companies. Less important to you are stability of the organization, the length of time an organization has been in business, and the business' plans for the future. You prefer a fast-moving company that will take risks to achieve its goals and objectives. The length of time the company has been in business is irrelevant. Maintaining status quo is unnecessary. You thrive on change, uncertainty and the upside of potential business risks, especially those associated with innovation. Stability for the long haul is not nearly as important as is working in an atmosphere that is charged with a sense of urgency and constant change.

Tags

clinical trials, pharmacovigilance, clinical monitoring, aggregate reports, PSURS, employee traing, global delivery, vendor management, site management, patient safety, adverse event reporting, case report form development, risk management, query resolution, global unblinding, medical case management, regulatory submissions, regulatory audits, protocol writing, protocol review, informed consent review, informed consent approval, study tool development, drug return, investigator recruitment, investigator selection, present at investigator meeting, 21 CRF, ICH-GCP, clinical study reports, global clinical matrix team participation, remote monitoring, pre-study visit, interim monitoring, closeout visit, study audits, regulatory query resolution, NDA approval, IND, data reconciliations, IRB submissions, medical device

Skills

pharmacovigilance, clinical trials, aggregate reports, IND subissions, PSURS, data reconciliations, protocol writing, IRB submissions, regulatory submissions, employee training, vendor management, global delivery, Presentation at investigator meetings, global unblinding of study, patient safety, medical case management, EDC databases, case report form design, investigator brochure writing, serious adverse event design, MedRa coding, writing pharmacovigilance plan, investigator brochure review, informed consent review, site audits, site selection, interim monitoring, study closeout visit, drug accountability, medical device, laboratory tests, hepatitis markers, drug labeling, PBER, drug destruction, compliance, regulatory

These are some of the questions we asked our climbers about their experiences with Pharmanet: