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Medical Director Pharmacovigilance

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Skills

Biologics Clinical Protocol Development CTAs Data Quality Management Dermatology IND Submissions Pharmacovigilance Regulatory Affairs Respiratory Indications Safety Reporting

As the Medical Director of Pharmacovigilance at Apogee, you will play a critical role in ensuring patient safety across our pipeline and maintaining data quality. This position is integral to supporting regulatory approvals and lifecycle management, while providing essential safety input for regulatory submissions and collaborating closely with various departments.

Key Responsibilities
  • Own safety across Apogee's pipeline and ensure data quality.
  • Support regulatory approvals and ensure patient safety.
  • Lead the preparation of Development Safety Update Reports (DSURs) and safety sections of protocols.
  • Provide safety input for regulatory submissions including INDs and CTAs.
  • Collaborate with Regulatory Affairs and Quality on CAPAs.
Required Skills & Qualifications
  • MD degree required.
  • A minimum of 8 years of pharmacovigilance experience.
  • Strong expertise in global regulatory requirements (FDA, EMA, MHRA, PMDA, ICH).
  • Experience with biologics and dermatology/respiratory indications is a plus.
  • Experience in late-stage development and submissions.
  • Willingness to travel up to 20%.

No forms. Your profile is generated instantly.

Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: Months

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