Chief Safety Officer

Company is searching for a creative, resourceful, strategic leader for a highly visible role, responsible for the medical oversight of global drug safety, pharmacovigilance activities for clinical trials, and product development.

This role will manage a team of approximately 30 FTEs with a targeted 10 additional openings in the next 12 months.

The ideal candidate will not only drive safety, but they must understand risk and how the drug development process is linked.

Solid data is being gathered, but this role, they will need to interpret the data and put it into perspective for the leadership team.

Reporting to the Chief Medical Officer, this role will provide leadership to the PV & Drug Safety Team and work cross-functionally to maintain standards for pharmacovigilance and risk management activities to ensure patient safety.

This position will have a high degree of visibility and impact across the organization.

As Company is expected to undergo significant growth in the upcoming years, this individual will need the skills to work effectively in a dynamic, cross-functional, global organization.
Provide dynamic leadership, strategic direction and governance of patient safety and pharmacovigilance activities across Company’s portfolio.

Support Safety Operations to establish and maintain policies and procedures for the Clinical Drug Safety Department.

Provide oversight for the medical review of serious adverse event reports to ensure accuracy, integrity, and completeness of safety information, and to ensure consistency of medical coding of safety data.

Ensure that aggregate data safety signals are identified promptly and communicated appropriately, including oversight of use of signal detection tools and other sources of potential product signals.

Ensure ongoing evaluation of the overall safety profile for Company’s investigational products, serving as the product safety expert, working in partnership with medical monitors to bring potential safety issues to the attention of the Clinical Team and upper management.

Support all departments with respect to safety related issues as required.

Provide input and review of responses to regulatory agency questions with regard to safety/ pharmacovigilance activities.

Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, annual reports, final study reports, IB, and other documents, as needed.

YEAR ONE CRITICAL SUCCESS FACTORS
The candidate will need to create a strategy and execution plan to bring Company’s Safety group to the next level of performance.

The candidate will need to build trust and connections with regulators.

They must be confident and capable.

He/She must build a collaborative relationship with FribroGen’s senior leadership.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS
12+ years’ relevant industry experience including experience leading multidisciplinary teams.

Pharmacovigilance experience, including regulatory filing experience, within the biotechnology, pharmaceutical or related industry.

Ability to combine pharmacovigilance expertise with exceptional leadership (strategic thinking, people, and resource management).

Oversight experience of global medical safety activities, operations, and risk management strategies in pre and post marketing environments.

Demonstrated knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing for clinical trial environments.

Robust knowledge of MedDRA dictionary with relevance to SAE analysis and SAE coding.

Familiarity with common Safety databases (e.g., Aris, AERS, Argus, etc.) preferred.

Ability to evaluate and interpret adverse event/serious adverse event reports and other documents to be used in Safety/Pharmacovigilance submissions.

Excellent clinical judgment and ability to communicate complex clinical issues in a scientifically sound and understandable way.

Experience working with all levels of management and consulting with key business stakeholders, e.g.

(business development) including an ability to influence for greater outcomes.

Entrepreneurial, small/high-growth company experience is preferred.

Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.

EDUCATION

Bachelor’s degree in life sciences or related discipline.

Medical or relevant advanced degree strongly preferred.