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Head of Drug Safety

Company: Aurinia Pharmaceuticals
Location: Rockville
Posted on: September 12, 2020

Job Description:

We are currently developing voclosporin, an investigational therapy, for the treatment of lupus nephritis (LN) and other proteinuric diseases. We are also advancing voclosporin ophthalmic solution (VOS), a topical formulation, for the treatment of dry eye syndrome (DES). And we are actively hunting for other innovative drugs which have the potential to change the lives of people with rare autoimmune and inflammatory diseases.

Job Description The Head of Drug Safety is a critically important position within Aurinia Pharmaceuticals supporting the growth plan of the company by building and leading the Global Drug Safety Function. Establishing effective collaboration across functional areas to align on a harmonized approach in identifying, evaluating, validating, and communicating safety issues, the Head of Drug safety will be Aurinia’s ambassador for global drug safety. This position requires a person with outstanding leadership qualities, technical and emotional intelligence.

Responsibilities:

The responsibilities of this role are three-fold and include programs/pipeline, business and people aspects.

Manage all pre- and post-marketing safety surveillance activities for Aurinia products (investigational and marketed) throughout lifecycle in compliance with ICH guidelines, FDA / EMA / applicable global health authority regulations related to Good Drug Safety Practices (GVP), and Aurinia policies and procedures

Develop, implement and maintain safety surveillance processes and practices that are compliant, robust, and right sized to support Aurinia business model; execute on these safety surveillance activities

Lead and/or provide input to global safety strategy for all programs ensuring proactive and continuous review and assessment of pre-clinical, clinical, and post-marketing safety data to ensure positive benefit-risk profile for all Aurinia programs in collaboration with key stakeholders

Establish effective collaboration with Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, and Medical Affairs and other functional areas

Coordinate safety data review activities, lead multidisciplinary Product Safety Review Committees and other Governance Committees

Responsible for the development and maintenance of Reference Safety Information (RSI) including Company Core Safety Information (CCSI in the Company Core Data Sheet (CCDS), Investigator Brochure (IB), and/or other product labeling and participate in Labeling forums ensuring accurate safety profile for all Aurinia products

Lead and/or contribute to risk analyses contributing to benefit-risk profile for Aurinia investigational and commercial products

Lead the design and implementation of safety risk mitigation strategies (REMS, Risk Management Plan, Post-Approval Safety Surveillance, Enhanced Drug Safety)

Ensure Drug Safety function collaboration and input for all Aurinia Clinical Development programs

Ensure Drug Safety collaboration and input to support Aurinia Commercial organization global launch activities for all program

Direct and oversee medical/scientific assessments of all safety data

Provide Drug Safety Leadership in the review, assessment and presentation of new safety findings at Development Technical Review Forum (DTRF) or other Safety Governance forums

Lead the safety aspect of interactions, including input and review of responses to regulatory agency questions, with Regulatory authorities worldwide

Collaborate in the development of scientific publications (abstracts, posters, papers) for scientific meetings/journals and approve the submissions from a safety perspective

Maintain knowledge of new Drug Safety/safety regulations, guidance from regulatory authorities and knowledge of disease indications for assigned programs

Business:

Establish overall Drug Safety objectives and long-range goals in line to ensure Corporate and Global Drug Safety objectives are met

Maintain department budget and adherence to business plan and overall goals and objectives of the company

Contribute to the development and support development of Drug Safety and other Aurinia standard operating procedures

Lead initiatives for process improvement and overall team effectiveness across programs

Participate in inspection readiness activities, internal audits, and external inspections

Support overall company strategy and corporate business development activities by providing Drug Safety medical/scientific expertise in due diligence, partnership committees, and other task groups

People:

Establish adequate staffing in drug safety to support the growth of the organization

Manage and administer all aspects of people processes related to the employee lifecycle. This includes the selection, hiring and training of personnel on company and department policies, systems and processes

Establish and monitor performance measures and objectives for the department; coaching and developing staff in alignment with these objectives

Qualifications Bachelor’s level degree with advanced degree preferably in scientific field; Healthcare professional degree (MD, MPH, PharmD, PhD, RPH)

A minimum of 12 years in a senior/advanced Drug Safety Science role within the pharmaceutical/biotechnology industry, with at least 5 years in supervisory capacity; other relevant experience may be considered

Desire and proven ability to manage and develop people and teams

Strong people management skills, willingness to help others succeed

Excellent communication and influencing skills within the function (up and down) as well as cross-functional; success influencing executives and senior level scientific management as well as external representation of company

Requires a high level of initiative and independence

Ability to navigate a fast-paced and dynamic work environment; ability to manage and prioritize multiple projects and demands simultaneously with ability to adjust to changing priorities and work effectively under pressure; organizational and prioritization skills a must

Able to interface well with all levels of personnel, including peers and other Development and Commercial department heads such as: Biometrics, Clinical Development, Clinical Operations, Commercial, Medical Affairs, Program Management, Regulatory Affairs, Quality

Capacity to produce high quality results across multiple programs and non-program initiatives and prioritize demands while working under short deadlines associated with a fast-paced dynamic scientific environment

Demonstrated knowledge of pharmaceutical research and development, global safety and Drug Safety regulatory environment with working knowledge of international regulations including but not limited to FDA, EMA, ICH guidelines and regulations pertaining to clinical development and post-marketing safety and their interpretation

Experience working in innovative and ground-breaking therapies with demonstrated track record of accomplishments with high visibility programs

Experience preferred in all phases of biologic, small molecule, mRNA and gene therapy drug development preferred

BLA/MAA experience preferred with success interacting with Regulatory authorities (FDA, EMA etc.) at type C, B, pre-BLA/MAA meetings, Advisory Committee meetings, or other scientific advice forums.

Experience in the principles and techniques of data analysis, interpretation and clinical relevance

Experience in developing and implementing risk management strategies and plans

Working knowledge of industry standard safety databases (ARGUS and ARISg), Regulatory databases, and other electronic data capture systems

MedDRA trained and working knowledge of MedDRA and WHODrug dictionaries

Real world experience supporting Drug Safety audits and/or health authority inspections

Proficiency with Microsoft applications including Excel, PowerPoint, Word and Sharepoint

Proficient in data analysis software and data presentation

Additional Information All candidate information will be kept confidential according to EEO guidelines.

Keywords: Aurinia Pharmaceuticals, Rockville , Head of Drug Safety, Other , Rockville, Maryland

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