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Opportunity: Medical Director, Medical Safety Assessment (#1001845) @ Bristol-Myers Squibb--New Haven, CT (US)
Submitted by Jody Aikawa; posted on Wednesday, October 06, 2010
Establish and chair the Medical Surveillance Teams (MSTs) for assigned products. Develop and implement risk management plans for assigned products according to the most current regulatory guidelines. Conduct proactive signal detection activities. Make labeling recommendations based on proactive signal detection and signal assessment activities. Make presentations as requested to senior medical review boards. Collaborate with non-clinical and clinical discovery/clinical research/medical affairs colleagues to review protocols and study reports and contribute to proactive planning of all studies related to safety assessments.

Provide medical evaluation of aggregate safety data, develop and write medical sections of periodic reports (PSURs, PADERs, ASRs) and ad hoc reports. Support departmental strategic initiatives. Provide a medical perspective into department standards, and support process improvement initiatives as needed. Ensure that the above tasks are performed in the most
efficient manner possible commensurate with quality, accuracy, and timeliness and in accordance with current global regulatory requirements and BMS cost effectiveness goals.

Promote collegiality and teamwork among peers, and mentor/support colleagues in the GPVE as a positive change agent. Attract, assess, retain and develop highly competent, experienced personnel who contribute positively to team spirit, creativity and alignment. Take responsibility for professional development of self and others, and share accountability for successful achievement of department-wide goals and objectives.

- MD or Equivalent Board certification and medical specialty preferred

- While the specific experience requirement will depend on the demonstrated achievements of the individual, 2-3+ yrs. in clinical practice or relevant setting preferred, 2-3+ yrs. of pharmaceutical industry experience preferred including some knowledge of drug development, 4-5+ yrs. of clinical safety experience

- Knowledge and skill in medicine and pharmaceutical product safety assessment

- Proficiency in medical evaluation of aggregated safety data

- Consistently demonstrates ability to build alignment and influence diverse, matrix teams and organizations

- Consistently demonstrates strategic leadership ability, strong execution skills, knowledge of planning processes and implementation, proactive organizational skills and demonstrated ability to lead cross-disciplinary teams

- Excellent communication skills, both written and oral

New Haven, CT

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