Pharmaceutucal Product Development Work Values

Daily Duties at Pharmaceutucal Product Development:

• Reviewed and approved over 38 local independent review board (IRB) informed consents in rescued pediatric clinical trial dealing with sponsors and legal for approval. • Monitored three Phase II-III rescued pediatric diabetes clinical trials for Bristol Myers Squibb for site selection, initiation, interim and closeout visits. • Monitored assigned sites for a Bristol Myers Squibb protocol on tight timelines of Phase II/III and helping to get Metformin NDA approved for pediatrics; and completed all closeout visits. • Coordinated regulatory training of employees from quality assurance. • Designed drug inventory spreadsheet for sponsor, which ensured all orders were submitted prior to its holiday shut down and resulted in considerable savings of both time and money. • Performed all site selection, initiation, interim monitoring, and closeout visits, and trained new clinical research associates (CRAs) in diabetes, immunology and virology studies. • Created table for screening blood glucose informed consents and documented 400+ screening consents for sponsor, Bristol Myers Squibb, in pediatric clinical trial for patent extension within tight deadlines. • Resolved case report forms discrepancies and protocol violations at site visit. • Monitored and unblinded all pediatric patients within 48 hrs of FDA approval of Metformin patent extension. • Collaborated with medical monitor to have pediatric patient experiencing suicidal ideation during the holidays and was seen by nutritionist. FDA later stated to the medical monitor how impressed he was by the diligence contact of the subject during weeks 8 through 12 study visits. • Trained and mentored new employees, taking them along on site visits and demonstrating auditing of files for completeness at PPD and the investigator site. • Monitored Phase IIIB Type 2 Diabetes randomized double-blind adult clinical trial for Takeda medical device study. • Therapeutic areas involved 3-4 plus central nervous system and cardiovascular AE/SAEs

What they like about Pharmaceutucal Product Development:

You give high priority to hiring firms with prestige. Market reputation and prestige of a firm may be determined through on-line research, and conversations with individuals working in your target industry. Note that firms "in the public eye" receive a great deal more critical publicity and attention than those operating with more anonymity. So as you assess your employment opportunities, be sure to seek out the positive aspects of the firm's reputation in addition to noting negative publicity the company may have received.

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 Pharmaceutucal Product Development: