APPROVED FOR REMOTE WORK

FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing, and commercializing a pipeline of first-in-class therapeutics. The Company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines for the treatment of unmet needs. The Company is currently developing and commercializing Roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA).

Additionally, Pamrevlumab, an anti-CTGF human monoclonal antibody, is in phase III clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), and Duchenne muscular dystrophy (DMD).

Position Summary

The Global Safety Lead (Director / Sr. Director) serves as the safety expert accountable for the global safety strategy and overall safety profile for assigned programs/products (investigational and marketed) throughout their product lifecycle. This includes leading all major pre- and post-marketing safety deliverables including signal detection/management, benefit-risk evaluation and risk management activities. This individual must effectively interface cross-functionally at all levels within the organization as well as with externally with regulatory agencies. This individual will work together with Drug Safety staff and other stakeholders (e.g. Clinical Development, Regulatory Affairs, Non-Clinical) in managing the safety assessment of products, including review of individual and aggregate safety data and the scientific literature, preparing safety reports and communicating changes in the product risk profile to internal and external stakeholders. The experienced individual must have executive presence, superb written and verbal communication skills, and the ability to work in a dynamic, changing environment to meet corporate and patient needs.

Key Duties & Responsibilities

• Manage all pre- and post-marketing safety surveillance activities for assigned products (investigational and/or marketed) throughout lifecycle in compliance with ICH guidelines, FDA / EMA / applicable global health authority regulations related to Good Pharmacovigilance Practices (GVP), and company procedures
• Lead and provide input to global safety strategy ensuring review and assessment of pre-clinical, clinical, and post-marketing safety data to ensure positive benefit-risk profile for assigned programs in collaboration with essential stakeholders
• Provide leadership and input for clinical development programs; work with Clinical Development, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities to contribute to overall study execution while ensuring safety strategy, quality, compliance and operational excellence
• Provide medical review of individual case safety reports and all safety analyses to ensure accurate coding (MedDRA and WHODrug), seriousness, expectedness and company causality assessment, appropriate medical interpretation, consistency in case assessment and accurate reporting to Health Authorities, Ethics Committees, and partners
• Lead and contribute to the preparation and review of medical/scientific assessments of safety data including safety-related section(s) for clinical, regulatory, and scientific documents including protocols, informed consent/assent forms, case report forms (CRFs), statistical analysis plans, clinical study reports/synopses, integrated summaries of safety (ISS), New Drug or Biologic License Applications (NDA/BLA), Marketing Authorization Applications (MAA), Common Technical Document (CTD) submissions, Regulatory Agency responses, IRB/EC requests, briefing books, manuscripts/journal articles and other documents, ensuring safety profile reflected for assigned products
• Direct the creation and maintenance of Company Core Safety Information (CCSI) and ensure implementation of CCSI in all Reference Safety Information (RSI) including Investigator Brochures (IBs), Company Core Data Sheet (CCDS), national labels and other associated product labeling
• Perform review of medical/scientific literature to identify literature relevant for signal detection activities and aggregate reporting for assigned products
• Lead signal detection activities to ensure signal identification, evaluation, validation, for assigned products including personal and aggregate data analyses; interpretation of safety signals and trends; documentation and communication of safety assessments (written and verbal) of safety risks in collaboration with important partners
• Lead on Safety Management Team (SMT), escalate emerging safety issues to FibroGen Global Safety Board
• Lead and contribute to the preparation of pre- and post- marketing aggregate safety reports including Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), IND Annual Reports, and 6-monthly Suspected Unexpected Serious Adverse Reactions (SUSARs) Line Listing Reports
• Communicate safety profile/topics across several regulatory safety documents for assigned products
• Lead risk-benefit evaluations, the preparation and review of Risk Management Plans (RMPs) for assigned products ensuring identification of risks, appropriate risk minimization and effectiveness measures in accord with regulatory requirements
• Provide guidance with adverse event (MedDRA) and drug (WHODrug) coding for clinical and post-marketing safety data
• Develop or contribute to development of departmental process improvement projects, including policies, Standard Operating Procedures and other relevant safety documentation
• Demonstrate knowledge and ensure compliance with current and applicable global PV regulations (e.g., CIOMS, EMA, FDA, ICH), internal SOPs and quality standards
• Involved in inspection readiness activities, internal audits and external inspections
• Participate in the PV vendor selection activities and contribute to the generation of Pharmacovigilance Agreements (PVAs)
• Provide safety expertise to due diligence activities
• Mentor junior staff; develop and provide training within specific areas of knowledge

Key Qualifications

• MD degree or equivalent (e.g., DO or MB) required, knowledge in either oncology or fibrosis is a plus
• 3-5 years of biopharma industry experience is required, with a focus on patient safety or prior pharmacovigilance experience preferred
• Good knowledge of pharmacovigilance regulations
• Proven evidence of effective delivery of high quality safety documents
• Knowledge of relevant concepts in epidemiology and statistics
• Effectively communicates in written and spoken English
• Communicates complex issues in an understandable, effective and relevant manner
• Strong influencing skills with the ability to explain and defend a position in the face of opposition
• Strategic focus to activities and planning, with proactive planning and prioritization skills
• Effective team member; takes ownership of appropriate issues and appropriately delegates
• Effectively applies processes across assigned team
• Technical expertise in patient safety gained from experience in a PV or a clinical background, including understanding of adverse events, adverse drug reactions, reporting systems, pharmacologic principles behind these adverse events, and measures to ensure patient safety
• Excellent analytical and problem solving skills
• Ability to provide effective and relevant review of complex documents

• Deep knowledge of the specific therapeutic area is strongly preferred
• Experience with interactions with major regulatory agencies is preferred

SALARY RANGE
$289,200.00-$339,700.00
FibroGen is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender identity/expression, creed, national origin/ancestry, age, alienage or citizenship, status, age, sex, sexual orientation, marital or domestic/civil partnership status, disability, veteran status, genetic information, or any other basis protected by law.FibroGen will consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance.

At FibroGen we continue to strive to build a diverse and equitable workplace; we share the typical minimum and maximum salary ranges on all job postings. For annual base pay, we typically set standard ranges for positions based on function and level benchmarks. Further, we establish fixed annual bonus targets, expressed at a % of annual base pay, based on level in the organization. Bonus awards are determined based on assessment of individual and corporate goal achievement. All compensation offers of employment are determined by multiple factors including a candidate’s relevant qualifications, work experience, skills, and other factors and may vary from the amounts listed above.

Notice to Recruiters and Search Firms
FibroGen does not accept unsolicited resumes or communications. Contact with a hiring manager or submission or presentation of candidates by recruiters or placement agencies without a current signed agreement with FibroGen will not constitute, in any form, a financial obligation or agreement for recruitment services or placement support or consulting fees.

E-Verify: Notice to all Prospective Employees

Job Type: Full-time

Pay: $289,200.00 - $339,700.00 per year

Please Note :
clarksqn.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, clarksqn.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.