Director, Drug Safety

Responsible for development of Drug Safety and Risk Management (DSRM) Departmental and contractor/vendor compliance programs, departmental continuous quality improvement (CQI) initiatives, and development of global CQI/quality for Drug Safety and Risk Management. The incumbent drives the creation of controlled documents for the Department in accordance with company policies and oversees the DSRM audit internal and external audit program. The incumbent is also responsible for oversight of compliance for internal and external partners.

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Qualifications

Essential:

• Master's level degree in medical or health sciences or the equivalent experience.
• Minimum of 9 years experience in the pharmaceutical industry in safety surveillance, regulatory affairs, quality assurance or clinical departments.
• Experience with US and global pharmacovigilance regulatory requirements.

Technical Skills:

• Excellent computer skills in a Microsoft environment.
• Prior experience with databases and database tools.
• Working knowledge of US, Canadian and international regulatory requirements.

Interpersonal Skills:

• Must have excellent communication skills.
• Must be able to influence/persuade others and have excellent negotiation skills.
• Ability to solve complex problems and provide creative solutions.
• Proven ability to build teams and consensus and interact collaboratively in a team environment.
• Ability to work in a multi-cultural environment.

Frequent inter-organizational and external contact, represents the organization in meetings or on teams.

Education

• Master's level degree in medical or health sciences or the equivalent experience.
• Minimum of 9 years experience in the pharmaceutical industry in safety surveillance, regulatory affairs, quality assurance or clinical departments.
• Knowledge and experience with US and global pharmacovigilance regulatory requirements

Biogen Idec is proud to be an Equal Opportunity Employer.

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