Medical Director – Drug Safety & Pharmacovigilance

Position Summary:

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.     

Key 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

Qualifications:

• 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.

#LI-Hybrid

Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $246,400 to $308,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.

Zenas believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Zenas’ competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.