Executive Director, Pharmacovigilance
Location: South San Francisco, California, United States
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.
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.
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