Global Safety Strategy Lead, Drug Safety & Pharmacovigilance

Scholar Rock; Cambridge (MA); On-site; USD 280,000 - 420,000; Full time

Job summary

A biopharmaceutical company seeks a Sr. Medical Director in Drug Safety & Pharmacovigilance in Cambridge, MA. This pivotal role requires an MD or equivalent degree and entails leading safety strategy and compliance efforts for drug development. Responsibilities include overseeing signal detection, conducting medical safety reviews, and ensuring adherence to regulations. Candidates should have over 5 years of experience in pharmacovigilance with a strong grasp of US/EU regulations. Competitive salary between $280,000 - $420,000 based on experience.

Qualifications

• 5 or more years of pharmaceutical experience in Drug Safety & Pharmacovigilance.
• High level of medical competence with the ability to balance it with industry standards.
• Prior IND and NDA/BLA regulatory interaction experience is highly desirable.

Responsibilities

• Lead and support development of pharmacovigilance strategies.
• Oversight of signal detection activities, managing safety information.
• Responsible for oversight of Product Safety Committee meetings.

Skills

Pharmaceutical experience in Drug Safety & Pharmacovigilance

Strong understanding of pharmacovigilance regulations in the US and EU

Experience in supporting drug safety activities in registrational clinical studies

Leadership and organizational skills

Scientific analysis and reasoning

Education

MD or MBBS or MD-PhD or equivalent medical degree

Job description

A biopharmaceutical company seeks a Sr. Medical Director in Drug Safety & Pharmacovigilance in Cambridge, MA. This pivotal role requires an MD or equivalent degree and entails leading safety strategy and compliance efforts for drug development. Responsibilities include overseeing signal detection, conducting medical safety reviews, and ensuring adherence to regulations. Candidates should have over 5 years of experience in pharmacovigilance with a strong grasp of US/EU regulations. Competitive salary between $280,000 - $420,000 based on experience.