Medical Director – Drug Safety & Pharmacovigilance

Zenas BioPharma•Waltham, MA

2d•Hybrid

About The Position

The Medical Director, Pharmacovigilance role is responsible for providing medical oversight of safety data from clinical trials to ensure proactive and timely benefit-risk assessments for all products in the Zenas portfolio. This is an individual contributor role reporting to the Head of Pharmacovigilance.

Requirements

MD with a minimum of 8 years Drug Safety/Pharmacovigilance experience in Biotech, Pharma or Clinical Research Organization
Working knowledge of relevant FDA, EU, ICH guidelines and regulations
Experience working with CRO/vendors, and relationship management preferred
Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way
Working knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding
Outstanding communication skills (verbal and written)
Ability to manage multiple projects in a fast-paced environment
Ability to effectively collaborate in a dynamic, cross-functional matrix environment
The ability to establish and maintain excellent relationships when dealing with sensitive and/or complex issues and tight timelines.
Ability to lead and influence project teams, committees, etc.
Demonstrate excellent leadership and communication skills.

Responsibilities

Performs and oversees medical review of safety events to ensure accuracy, integrity and completeness of safety information, and consistency of medical coding of safety data
Identifies and evaluates safety signals through the assessment of single case safety reports and aggregate trend analyses
Participates in cross-functional aggregate medical review with the medical monitors.
Provides CRO feedback regarding quality of narratives and case processing.
Leads the internal safety committee meetings and all signaling activities.
Assists in authoring and reviewing aggregate reports such as DSURS.
Ensures the ongoing evaluation of the overall safety profile for investigational products, serving as the product safety expert to bring potential safety issues to the attention of the clinical team and leadership
Contributes to safety sections of clinical documents, including preparing, review and approval of the safety portion of protocols, IBs, ICFs, CSRs, integrated summary of safety (ISS), and other documents, as needed; Drives annual DSUR preparation.
Provides input and review of responses to regulatory agency questions regarding patient safety
Establishes and maintains policies and procedures for the PV function