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Executive Director, Pharmacovigilance

Company: Assembly Biosciences, Inc.
Location: San Francisco
Posted on: February 25, 2021

Job Description:

Summary:-- The Executive Director, Pharmacovigilance will lead the Pharmacovigilance function at Assembly Biosciences, including ongoing signal detection monitoring, oversight of safety collection, processing, and reporting activities for Assembly's clinical development portfolio. In this leadership position, the Executive Director will work closely with the Clinical Development extended team to ensure appropriate oversight for safety and pharmacovigilance activities. Key Responsibilities include:

  • Build and lead the company's drug safety and pharmacovigilance function
  • Manage compliance with standard operating procedures, regulatory safety and pharmacovigilance in compliance with national and international regulations, including global, regional and country regulations for the reporting of adverse events to regulatory agencies
  • Direct, control and implement all pharmacovigilance activities according to standard operating procedures as well as FDA, EU and international regulations
  • Provide appropriate oversight of the PV vendor performing case management and study support activities
  • Provide appropriate oversight of safety database related activities
  • Review and contribute to clinical trial safety including safety monitoring plan and data analysis
  • Manage development of Pharmacovigilance agreements (PVAs) and safety exchange agreements (SDEAs) with partners in support of PV collaborations
  • Primary contributor to aggregate safety reports, including DSURs, Health Authority SAE reporting and other safety aspects of regulatory filings
  • Ensure the uniform and timely processing of adverse event reports
  • Collaborate with functional leaders to set strategy and shared objectives
  • Develop and maintain current pharmacovigilance knowledge and ensure that Clinical Development team is aware of new and existing relevant procedures, guidance, and regulations
  • Coordinate the development of internal safety SOP/policies
  • Interface with internal and external collaborators to develop programs and processes to meet regulatory reporting requirements Preferred Qualifications include:
    • Advanced degree in a scientific discipline with 15+ years of relevant pharmacovigilance experience
    • Significant experience working with the FDA and other regulators
    • Substantial experience in all aspects of pharmacovigilance, including standard operating procedures, regulatory safety and pharmacovigilance in compliance with US and ex-US regulations
    • A thorough understanding of relevant guidance and regulations and requirements
    • Experience in global clinical trials and global regulatory filings preferred
    • Has exceptional qualitative and analytical/quantitative skills
    • Collaborates with diverse stakeholders and builds strong, cross functional relationships
    • Manages competing agendas and priorities
    • Consistently demonstrates strategic thinking about business initiatives with an entrepreneurial spirit
    • Exceptional verbal and written communication skills
    • Excellent organizational, interpersonal, and negotiation skills
    • Ability to evaluate CROs and other vendors that may assist Assembly Biosciences in fulfilling safety oversight and reporting obligations About Assembly Bio Assembly Biosciences (NASDAQ: ASMB) is a clinical stage biopharmaceutical company with cutting-edge therapeutics potentially capable of improving millions of lives around the world. We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add great people to our dynamic team who are driven to transform the lives of patients. We are currently focused on the development of two intelligently designed, scientifically novel clinical platforms: An HBV program intent on creating a new class of oral therapeutics to finally cure hepatitis B. Our program is built on ingenuity, vision and experience and has the potential to improve cure rates for individuals with chronic hepatitis B (HBV) in our lifetime. Our strong scientific expertise in discovering small molecules targeting the HBV core protein has made us a leader in the field. A Microbiome program of potentially life-changing oral live biotherapeutics to transform the treatment of an entire range of diseases linked to the microbiome. We believe our Microbiome platform represents a best in class approach, translating naturally evolved, bacteria-host pharmacological interactions into rationally selected, live oral biotherapeutics. Assembly Bio has a strong balance sheet and is well-positioned to advance our innovative research and potential medicines in HBV-cure and the Microbiome. Headquartered in South San Francisco, CA, Assembly Bio also operates a microbiome manufacturing facility in Groton, CT, and has offices in China.-- EEO Statement Assembly Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics. How did you hear about Assembly Biosciences?
      If you were referred by an employee, who referred you?
      Will you now, or in the future, require visa sponsorship for employment? --*
      -- U.S. Equal Opportunity Employment Information (Completion is voluntary) Individuals seeking employment at Assembly Biosciences, Inc. are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. Gender Please select Are you Hispanic/Latino? Please select Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Veteran Status Please select Form CC-305 OMB Control Number 1250-0005 Expires 05/31/2023 Voluntary Self-Identification of DisabilityWhy are you being asked to complete this form? We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years. Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . How do you know if you have a disability? You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition. Disabilities include, but are not limited to:
      • Autism
      • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
      • Blind or low vision
      • Cancer
      • Cardiovascular or heart disease
      • Celiac disease
      • Cerebral palsy
      • Deaf or hard of hearing
      • Depression or anxiety
      • Diabetes
      • Epilepsy
      • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
      • Intellectual disability
      • Missing limbs or partially missing limbs
      • Nervous system condition for example, migraine headaches, Parkinson's disease, or Multiple sclerosis (MS)
      • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression Disability Status Please select 1 Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp . PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Keywords: Assembly Biosciences, Inc., San Francisco , Executive Director, Pharmacovigilance, Executive , San Francisco, California

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