Senior Director, Drug Safety and Pharmacovigilance at The Elle Group in Boston, Massachusetts

Posted in Other 13 days ago.

Type: full-time





Job Description:

The Senior Director, Drug Safety and Pharmacovigilance is responsible for leading safety surveillance and ensuring compliance with legal and regulatory requirements for pharmacovigilance, signal management, and risk management.

- MD degree and board certification preferred

- First in Human-Post Marketing experience

- 7+ years of experience as a safety physician in the industry

- Expertise in drug safety leadership

- Proficiency in safety data visualization tools

- Excellent communication and presentation skills

- Experience in authoring safety reports

- Knowledge of regulatory guidelines (FDA, EMA, GCP/GVP/ICH)

- Understanding of observational studies and statistical methods

- Exceptional interpersonal skills

- Ability to present recommendations effectively

- Application of pharmacology, chemistry, and toxicology*

- Capability to thrive in a fast-paced environment

- Boston-based- onsite 3 days a week requirement
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