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| ASSOCIATE DIRECTOR DRUG SAFETY NJ Open (J#11333) Education: Ph.D. Degree Experience: 4 - 9 years The Medical Evaluation Group is a team of physicians and scientists dedicated to safety signal detection and risk management ensuring the safe use of Roche products and thereby contributing to Roche Products business success throughout the lifecycle. Support the proactive identification of potential safety signals reported from clinical trials of drugs in development, as well as, the pharmacovigilance of marketed products. Critically evaluate potential safety signals and where necessary propose strategies to enable further assessment of safety signals. Assist in the development of risk management strategies for significant identified safety risks. Provide Drug Safety support for Roche clinical teams. Participate in cross functional clinical team meetings, scientific advisory boards and may be involved in health authority discussions/meetings Medical input into periodic reporting documents (PSURs; Annual and Periodic Safety Reports; Quarterly Summary Reports; etc), Core Data Sheets, Investigators Brochures, Clinical Study Reports. May be involved in medical evaluation of single case reports. May author/co-author and/or assist in ASIME, issue workups, query responses (Health Authorities, internal requests, health care providers) Qualifications: MD, PhD, PharmD Pharma Industry or healthcare environment experience Strong written and communication skills; excellent computer skills Ability to evaluate and synthesize scientific data (analytical thinking) Excellent problem solving skills Team player with ability to function in multi-disciplinary environment Self-motivated, able to prioritize and plan effectively Good organizational and time management skills Attention to detail | |||
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