Job Description

Department: Pharmacovigilance

Head of Drug Safety & Pharmacovigilance

Summary:

The Head of Drug Safety and Pharmacovigilance responsible for the global, strategic and operational oversight of the quality and compliance of pharmacovigilance activities at TB Alliance worldwide in accordance with global legislation and regulations. This includes management of the safety vendors across trials, accountable for aggregated and expedited safety reporting and communication to the Health Authorities, investigators, clinical study teams and to relevant business partners. The Head of Drug Safety and Pharmacovigilance develops and maintains the safety related SOPs and guidelines for TB Alliance. This individual will also serve as an external representative of TB Alliance as needed in the context of collaboration with business partners, ensuring that the exchange of safety clinical data is timely and medically sound. This position reports to the Chief Medical Officer.

Position description:

• Oversee all medical pharmacovigilance (PV) activities including signal detection, safety review across trails, DSUR and annual report development across compounds, as well as single case review and development.
• Chair the safety management team, which oversee safety monitoring for all compounds and characterizes the safety profile and risk-benefit evaluation for individual compound at TB Alliance.
• Responsible for determining optimal timing for yearly IB updates across compounds. Within this role, he / she may be responsible for managing and optimizing content of the yearly updates.
• Contribute to study design and protocol development, as well as the analysis and synthesis of trial data with specific attention to safety sections and benefit-risk evaluation.
• Manage and ensure the PV related operational activities.
• Lead the characterization of safety profile of TB Alliance compounds across the life cycle of drug development, accountable for signal detection and safety review across trials at compound-level with collaborations with internal cross functional team and external business partners as applicable.
• Provide medical oversight to contractors, consultants and non-physician team members involved in preparing varies written safety documents.
• Manage and optimize IB, DSUR and annual report development at TB Alliance across compounds. Perform thorough medical review of the IBs, the aggregated safety reports and be accountable for medical review and evaluation of expedited cases.
• Anticipate safety concerns and influence relevant TB Alliance functional teams to minimize/mitigate patient impact by active participation in the design of the study/clinical protocols.
• Contribute to the analysis and synthesis of trial data with special attention to safety sections and benefit-risk.
• Act as a safety data characterization and benefit-risk assessment reviewer and contributor on NDA and MAA dossiers and labelling update.
• Review TB Alliance\xe2\x80\x99s partner study protocol design and other trial documents and provide medical input as appropriate.
• Provide input to business development regarding needs associated with licensing activities.
• Ensure compliant PV and appropriate processes are in place for the collection, collation, evaluation and submission of individual case safety reports and aggregate reports in accordance with international regulatory requirements.
• Ensure effective system to monitor compliance with reporting requirements including root cause and corrective/preventive actions. Serves as primary liaison with QA during PV inspections and collaborates in preparation of responses to inspection observations.
• Ensure required outputs are available and accurate to support expedited/periodic reporting, signal detection, and regulatory queries and regulatory inspections.
• Provide identification and oversight of vendors.
• Oversee development, execution, and maintenance of Safety Data Exchange Agreements for all development, licensing, commercialization, and distribution partnerships to meet regulatory requirements and protect TB Alliance assets.
• Lead the operations and strategy of the department. Alerts senior management to significant deficiencies in quality and compliance standards related to PV activities and ensures corrective/preventive actions are implemented.
• Effectively manages and leads the pharmacovigilance team. Ensures that a scalable and compliant Quality and Operations organization is in place. Exhibits a culture of leadership, innovation and problem solving.
• External representative of TB Alliance in the context of collaboration with business partner. Ensure the collaboration is medically sound, compliant to regulations and written agreements. Manage and maintain good working relationship with business partners.
• Responsible for compliance with applicable GxP regulations in performing the functions of the job and attendance at annual GxP or other applicable regulatory trainings provided by TB Alliance.

Ideal candidates will have:

• Medical Degree.
• A minimum of 10 years in the industry with 5 years in Pharmacovigilance, with prior oversight of PV compliance, quality and training, external contracts, and database systems.
• Experience in quality systems, establishing and tracking performance metrics, compliance monitoring, the development and maintenance of SOPs and training programs, and PV systems/databases.
• Solid knowledge of and experience with FDA and EU regulations and ICH guidelines related to pharmacovigilance including safety monitoring and reporting in clinical trials, post-marketing surveillance, case processing, safety agreement requirements, and reporting to Health Authorities worldwide.
• Experience with pharmacovigilance inspections by major global Health Authorities.
• Ability to assess evolving regulatory landscape, weigh possible courses of action, provide advice, and make decisions.
• Understanding of a large-scale electronic data storage and retrieval system.
• Proven ability to work well and effectively in a team environment. Demonstrated experience in building and maintaining strong long-term professional working relationships.
• Excellent interpersonal, communication, analytical, and organizational skills.

Location:

Salary and Benefits:

As part of our overall compensation package, we offer comprehensive health benefits, generous retirement contributions, and work/life flexibility designed to support you and your family. Starting salary is expected to be in the range of US$213,000 - $267,000 exact salary will be commensurate with skills and experience and adjusted to reflect local currency for candidates outside the US.
Along with a competitive salary, TB Alliance offers superior employee benefits centered on medical insurance with very low co-payments, high levels of coverage, resulting in overall coverage valued at the 95th percentile. The package also includes vision, and dental insurance for employees, spouses, domestic partners, and dependent children, life insurance/accidental death. 100% of employee benefit costs are paid by the organization, with coverage effective day one of employment. TB Alliance also offers a retirement savings program in the form of a 401k plan with generous employer contributions and employee matching. Additionally, TB Alliance provides generous paid time-off, paid parental leave, paid family leave, flexible-hybrid work schedules, tuition reimbursement, student loan repayment assistance, as well as professional development opportunities for all staff.




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Instructions:

To apply for this position, send resumes and cover letters to jobs@tballiance.org. Please include the position title in the subject line.

Organizational Information:

TB Alliance is a not-for-profit organization dedicated to the discovery and development of better, faster, affordable tuberculosis drugs that are available to those who need them.Through innovative science and with partners around the globe, we lead a global effort to ensure development of and equitable access to faster, better tuberculosis cures that will advance global health and prosperity. With an annual operating budget of approximately $60 million, the TB Alliance leads the advancement of the most comprehensive R&D portfolio of TB drug candidates in history. Additionally, the TB Alliance drives efforts to ensure regulatory approval, country adoption of new regimens, and widespread availability of new drug regimens to patients. For more information, please access the website: www.tballiance.org.