DTU, Danmarks Tekniske Universitet
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Job ad: Senior Safety Physician
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Senior Safety Physician
Are you passionate about pharmacovigilance and leadership? Do you want to be part of a committed medical safety team engaged with the clinical development and life-cycle management of psychiatric medicine? Do you have a strong background in pharmacovigilance and preferable also as a clinician?
Reporting to the Director of Medical Safety – Psychiatry, your responsibilities will be to lead safety teams in the Medical Safety – Psychiatry Department. You will be responsible for all aspects of clinical safety & surveillance related to allocated psychiatry projects/products.
Key responsibilities will include:
- Authorship, medical review and approval of individual case reports, PSUR, DSUR's, RMP's and regulatory response documents
- Review and input to the safety components of the target profile, clinical development plan, clinical study protocols, IB's, study reports and regulatory documents
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