Senior Safety Physician, Lundbeck

Annoncencen er hentet fra: Jobindex

LundbeckSenior Safety Physician

Lundbeck, Copenhagen

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, /DSURs, RMPs and regulatory response documents
  • Review and input to the safety components of the target profile, clinical development plan, clinical study protocols, IBs, study reports and regulatory documents.

Læs mere