Sr. Medical Director, Drug Safety and Pharmacovigilance

Extensive experience with all aspects of safety signal evaluation, including review and analysis of data, collaboration with cross-functional team members and senior management, authoring of required regulatory correspondence, and safety label updates.

Experience in both clinical development and post-marketing safety

Experience with Regulatory submissions for NDAs, EU MAAs, and other countries’ Regulatory reviews

Demonstrated ability to successfully manage a drug safety team or drug safety CRO for a clinical development program with responsibilities for expedited reporting, on-time DSUR preparation

Experience in drug safety audits and agency inspections

Intimate knowledge of GCP and strong working knowledge of FDA, Good Clinical Practices, and ICH regulations and guidelines

Market leading compensation

401K with 100% employer match on first 3% & 50% on the next 2%

Employee stock purchase program

Pre-tax commuter benefits

Referral program with $2,500 award for hired referrals

Medical Director, Drug Safety and Pharmacovigilance, is responsible for the overall risk management and safety strategy of assigned products, including both internal and external engagement with key collaborators.

Oversight and understanding of all aspects of the assigned product’s safety profile from clinical development to post-approval safety surveillance, including management of CROs and other partners that provide clinical and safety data

In collaboration with the regulatory and clinical development team, establish the safety strategy for marketing authorization applications, including the preparation of CTD documents, engagement with regulatory authorities, and authoring responses to inquiries

Support the clinical development team in the review of key documents, including protocol and ICFs

Manage the drug safety contract service organizations (CROs) for clinical programs to ensure compliance with expedited reporting, manage on-time and scientifically sound DSUR preparation, and ensure the drug safety functions of the CROs meet corporate goals and key performance indicators

Assist in the medical review of adverse event reports; manage preparation and submission of drug safety expedited reporting in compliance with regulations, when necessary

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.