Director, Pharmacovigilance (PV) Scientist na Zenas BioPharma

Position Summary:

This position is a unique opportunity to combine both operational PV support and analytical PV support.  This Director level PV Scientist will be responsible for clinical trial PV support for the assigned product including case oversight, signaling, aggregate report authoring, and creation/maintenance of core study documents such as ICFs, IBs, and protocols for PV.  This individual will sit on core study teams, working in a cross-matrix environment, and is an individual contributor role.

Key Responsibilities:

• You will work collaboratively with the medical monitor for timely review of SAEs, the development of analysis of similar events, and procurement of required follow-up information
• Ensure that all SAEs are reviewed, processed, and expedited in accordance with global regulations
• Project lead for signaling for assigned products including facilitation of cross-functional Safety Management Committee meetings including setting agendas, creating materials, presenting to the committee, and all associated documentation
• Provide PV subject matter expertise in all areas of clinical development including core study document development and maintenance (CRFs, ICF, protocols, IBs), regulatory requests for information, and safety crisis management
• Project lead and author on the annual Developmental Safety Update Reports
• Development and/or support of standard operating procedures (SOPs)

Qualifications:

• Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent healthcare degree with pharmaceutical industry background and proven competence in PV
• Minimum 8 years’ pharmaceutical industry experience in PV
• Knowledge of MedDRA terminology and its application
• Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data
• Experience in the preparation and authoring of pre- and post- aggregate safety reports
• Thorough understanding of the drug development process and context applicable to safety surveillance activities
• Ability to execute and follow-through to completion and documentation
• Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view
• Independently motivated, detail oriented and good problem-solving ability
• Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities
• Excellent communication skills and ability to influence multiple functions
• Experience working on BLA/MAA filings is preferred

#LI-Hybrid

Zenas is committed to fair and equitable compensation practices. The base salary pay range for this role is $183,200 to $229,000. 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.