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Associate Director, Clinical Safety Surveillance
position and advance your career in the
Pharmaceutical industry today.
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Associate Director, Clinical Safety Surveillance : Takeda Pharmaceuticals North America
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| Description |
Takeda Pharmaceuticals North America has built a solid foundation on successful products, principles, people, and research. We currently have the following position available in Lake Forest, IL:
Associate Director, Clinical Safety Surveillance-0900643
This position will direct the overall functioning of pharmacovigilance clinical safety surveillance. Position will ensure timely and efficient collection of safety data to regulatory agencies and partners.
ACCOUNTABILITIES:
- Implement appropriate processes to monitor the safety in clinical studies of marked products and compounds in development
- Ensure collection and processing of data are in compliance with GCP and all applicable legislation
- High-Impact Global Decisions: Coordinate the review and interpretation of safety data from ongoing internal and external studies and contribute to decisions that impact development in regards to safety issues (risk), such as "go/ no go" decisions or modification of development plan or study design that may have a significant impact on timelines or product labeling
- Co-ordination of operational activities globally for identification and appropriate escalation of issues to VP, Pharmacovigilance
- Liaise with Senior Medical Director Pharmacovigilance and VP, Pharmacovigilance to anticipate regulatory implications of emerging safety issues and develop strategies for handling/managing such issues
- Perform safety analysis and risk assessment of in-licensing compounds (due diligence)
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| Requirements |
EDUCATION/EXPERIENCE:
- Degree level qualification (e.g. Bachelors degree) in scientific/medical field and higher degree or specific pharmacovigilance qualification preferred
- Minimum 8 years experience in pharmacovigilance
- Minimum 5 years experience in people management and well-developed skills in teambuilding, motivating and developing people
- Expert knowledge of clinical trial and pharmacovigilance methodologies including safety profile and risk/benefit analysis and detailed comprehension of global regulatory requirements
TRAVEL REQUIREMENTS:
10-15% US and Ex-US
To learn more about this position and to apply online, please visit tpna.com/positions.asp#top and reference job number: 0900643.
TPNA is an Equal Opportunity Employer. |
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| Contact Info |
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To learn more about this position and to apply online, please visit tpna.com/positions.asp#top and reference job number: 0900643. |
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