FDA-BeiGene-ACPHS pharmacovigilance two-year fellowship

Overview

This two-year fellowship in pharmacovigilance and medication safety is a collaboration of BeiGene, the US Food and Drug Administration (FDA) Office of Surveillance and Epidemiology (OSE) and Albany College of Pharmacy and Health Sciences (ACPHS).

This partnership of a global pharmaceutical company with a regulatory agency and an academic institution will provide a rich and rewarding experience for the fellow.  In addition, the three partners want to build on their individual strengths and common objectives to create a compelling project that will span the two years.

BeiGene, a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. Our vision is to transform the biotechnology industry, creating impactful medicines that will be affordable and accessible to far more cancer patients around the world.  Our mission is to build the first next-generation biotechnology company- one that expands the highest quality therapies to billions more people- through courage, persistent innovation, and challenging the status quo.

Currently, employees are located in Asia-Pacific, United States and Europe. BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients.

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. At BeiGene, we are passionate about our people, science, and creating a lasting impact. These priorities are of utmost importance to our organization. We strive to build a global organization recognized for its impact in cancer research and drug development, talented people, and integrity.  For more information, see www.beigene.com.

FDA Office of Surveillance and Epidemiology (OSE) monitors and evaluates the safety profiles of drugs available to American consumers using a variety of tools and disciplines throughout the life cycle of the drugs. OSE maintains a system of postmarketing surveillance and risk assessment programs to identify adverse events that did not appear during the drug development process. OSE evaluates more than 2 million adverse event reports submitted every year to FDA's MedWatch program. Staff in the Office of Surveillance and Epidemiology use this information to identify drug safety concerns and recommend actions to improve product safety and protect the public health.

The Regulatory Science Staff (RSS) in OSE is responsible for providing leadership, coordination, and support for OSE’s regulatory science activities in the areas of risk management, pharmacovigilance, medication error detection and prevention in addition to epidemiology and health informatics.

The Regulatory Information System (RIS) Program under RSS manages mission critical systems (e.g., FDA Adverse Event Reporting System (FAERS) and the Phonetic and Orthographic Computer Analysis (POCA)), implements and maintains data standards required for coding and reporting safety data with medical accuracy and consistency, and  leads innovative projects in the area of artificial intelligence to improve the day-to-day management and analysis safety reports.

Since 1881, Albany College of Pharmacy and Health Sciences has been committed to the advancement of health care and the development of leaders in the profession of pharmacy. The College serves the educational needs of approximately 1,500 students across two campuses in Albany, NY and Colchester, VT. Pharmacy Practice faculty at ACPHS have enjoyed collaborative relationships with experiential sites offering experiences in medication safety and pharmacy informatics since 2004.

The ACPHS component of the fellowship will provide a series of field-based experiences that will allow the fellow to participate in the diverse aspects of medication safety within institutional pharmacy practice and observe how these activities relate to pharmacovigilance, informatics, and regulatory issues that support safe medication use.

Settings

In the first year, the Fellow will work full time at BeiGene on campus at either Emeryville, CA, San Mateo, CA, or Ridgefield Park, NJ.  Following that, the Fellow will spend four months at Albany College of Pharmacy and Health Sciences in Albany, NY.  Finally, during the last eight-nine months, the Fellow will work at the FDA OSE, White Oak Campus, Silver Spring, Maryland.

Candidates must be able to report to each of the three working sites (i.e. BeiGene, ACPHS and FDA) as required.  Relocation support will not be provided.

Objectives of the fellowship

• Gain extensive understanding of the importance of pharmacovigilance and medication safety across the drug development lifecycle
• Lever strategic cross-functional interactions across BeiGene, the FDA, and ACPHS, including those that will support data analytics/informatics longitudinal project (to be finalized once candidate has been identified) that impacts pharmacovigilance and that has potential for publication and presentation
• Overview the discipline of pharmacovigilance and experience functional core activities including safety data acquisition, medication errors, adverse event case management and evaluation, information technology/informatics, regulatory reporting, inspection readiness, aggregate safety reporting, signal detection and validation, risk assessment, and risk communication
• Gain exposure to applied technologies and innovation developments within the pharmacovigilance space
• Enable fellow to acquire information technology and health informatics skills
• Provide field-based experiences in institutional pharmacy settings that develop the fellow’s understanding of the systems-based approach to improving medication-use safety.
• Provide opportunities to take part in quality improvement projects to understand organizational medication safety risk, and identify risk reduction strategies.
• Offer teaching opportunities for undergraduate education and for presentation to fellowship partners through an additional seminar series.

Successful candidate will have

• Interest in deepening understanding of the contributions pharmacovigilance makes to patient safety and public health
• Interest in applying PharmD education and training to this field
• Aptitude to analyze and deliver data and outputs to internal and external stakeholders, including regulatory agencies, national competent authorities, and ministries of health in a globally regulated environment
• Ability to work in a dynamic environment with globally located, multi-cultural and cross-functional teams

Candidate competencies

• Ethics – Treats people with respect; inspires the trust of others; works with integrity and ethically in accordance with partners’ Codes of Business Conduct and Ethics, policies and procedures
• Planning/Organizing – Prioritizes and plans work activities; uses time efficiently; completes administrative tasks correctly and on time; follows instructions and responds to management direction 
• Communication – Listens, requests clarification; responds well to questions; speaks clearly and persuasively in positive or negative situations; writes clearly and informatively; able to read and interpret written information
• Teamwork – Balances team and individual responsibilities; gives and welcomes feedback; contributes to building a positive team spirit; puts success of team above own interests; supports everyone's efforts to succeed; contributes to building a positive team spirit; shares expertise with others
• Adaptability – Able to adapt to changes in the work environment; manages competing demands; changes approach or method to best fit the situation; able to deal with frequent change, delays, ambiguity, or unexpected events
• Technical Skills – Assesses own strengths and development areas; pursues training and opportunities for growth; strives to continuously build knowledge and skills; shares expertise with others 
• Dependability – Follows instructions and responds to management direction; takes responsibility for own actions; keeps commitments; commits to long hours of work when necessary to reach goals; completes tasks on time or notifies appropriate person with an alternate plan
• Quality – Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality 
• Analytical – Synthesizes complex or diverse information; collects and researches data; uses intuition and experience to complement data
• Problem Solving – Identifies and resolves problems in a timely manner; gathers and analyzes information skillfully 
• Project Management – Communicates changes and progress; completes projects on time and within budget