Drug Safety Director-Pharma
MA
Type:
Full-Time
Category:
Other Area(s)
Job ID:
748
Opportunity Description:
(508) Area Code
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.
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 pharmacogivilance 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.
Able to make decisions: • Across departments.
Able to make decisions by: • Without consulting with line manager or project manager.
Takes the initiative to communicate issues: • Across project teams and departments.
Able to handle a large volume of highly complex tasks: • Without supervision
Able to interact with team members: • On multiple studies and in multiple departments.
Able to manage work: • On one, or sometimes more than one, drug program.
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.
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