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Opportunity: Associate Director, Medical Safety Review @ Bristol-Myers Squibb--Trenton, NJ (US)
Submitted by Jody Aikawa; posted on Wednesday, December 09, 2009
RESPONSIBILITIES:
- Provides medical review of individual serious spontaneous reports of adverse events, performs causality assessment and determines regulatory reportability of clinical trial cases for assigned products and across therapeutic areas

- Ensures complete and timely reporting of medical cases to regulatory authorities globally

- Collaborate with QST to ensure consistency of work practices and SOPs

- Demonstrated ability to apply Bristol-Myers Squibb (BMS) operating philosophy and operate within company policies and procedures and appropriate regulations

- Partner with GPVE personnel from other functions AE processors, safety scientists and safety assessment group physicians in evaluating the safety profile of BMS compounds

- Identifies potential safety signals and informs the appropriate safety assessment physician of all potentially important cases and issues

- Collaborates with other BMS colleagues to address safety concerns

- Deals with safety related issues using critical medical and regulatory analytical strategies to develop optimal solutions

- Works closely with colleagues in QST to identify and implement new and more efficient processes for safety reporting and risk assessment

REQUIREMENTS:
- MD or equivalent. Education preferred: Board certification and medical specialty preferred

- Minimum of 2 to 4 years in clinical practice or relevant setting

- Minimum 1 to 3 years in pharmaceutical industry clinical research, pharmacovigilance or Medical Affairs or equivalent

- Knowledgeable and skilled in medicine and pharmaceutical product safety

- Experience applying medical knowledge to the interpretation of individual case review

- Experience with reporting of individual adverse events

- Previous experience in the safety field and or pharmaceutical industry

- Experience applying medical knowledge to the interpretation of individual case review

- Experience working in a team environment, including supporting other team members when necessary; promote collegiality and teamwork among peers

- Ability think clearly and decisively and present independent, reasoned solutions to identified safety issues, helps to drive consensus of opinion, and catalyzes action to meet critical regulatory objectives

- Demonstrated creative problem solving skills that enact change and drive continuous improvement

- Seeks to develop self and others. Aligns objectives with organizational goal

- Excellent oral, and written English skills excellent communication, interpersonal and time management skills

- Demonstrated flexibility, open mindedness and adaptability in a rapidly changing environment

- Ability to build and manage interrelationships by motivating and inspiring others

- Is an active, high energy proponent of the company's commitment to public health

- Influences and impacts others through clear reasoned argument, helps to drive consensus of opinion, and catalyzes action to meet critical regulatory objectives

- Represents GPVE within areas of responsibility and competence and experience. Ensures that the above tasks are performed in the most efficient manner possible commensurate with quality, accuracy, and safety in accordance with company cost effectiveness goals

LOCALE: Trenton, NJ

SALARY & COMPENSATION: Negotiable

HOW TO APPLY:
To apply for this position please copy and paste the following URL into your browser: [link]

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