SENIOR MEDICAL DIRECTOR, PHARMACOVIGILANCE

At ACELYRIN, INC., the patient is at the center of our culture and our business. We are guided by our values of courage, compassion, collaboration, innovation, and a sense of urgency. Our key value of courageous caring means putting patients first and having the courage needed to quickly solve challenging issues, we strive to redefine what is possible and quickly bring innovative therapies to bear against serious diseases.

Location: South San Francisco, CA; Agoura Hills, CA; Remote candidates will be considered

Job Title: Senior Medical Director, Pharmacovigilance

Reports To: Executive Director, Safety and Pharmacovigilance

Function: Pharmacovigilance

Job Type: Full time

Position Summary:

The Senior Medica Director, Pharmacovigilance (PV), will provide clinical/scientific/pharmacovigilance expertise to lead signal detection, benefit-risk evaluation, and risk management activities in support of ACELYRIN's products throughout their lifecycle. This includes the development of processes to support the proactive identification, evaluation, and risk management of safety risks for assigned ACELYRIN products. This individual will lead surveillance activities from various sources including pre-clinical studies, clinical studies, scientific literature and other sources. This individual will also contribute to a full range of pharmacovigilance activities including but not limited to PV department organization and infrastructure development. In addition, she/he will also function in a company matrix environment collaborating with several key groups including, but not limited to, Clinical Operations, Biometrics, Data Management, Clinical Development, Regulatory Affairs, Medical Affairs, and Quality Assurance.

Responsibilities:

* Provide dynamic leadership, strategic direction and governance of patient safety and pharmacovigilance risk management activities across ACELYRIN's portfolio
* Lead signal detection and risk management activities for assigned products which includes individual and aggregate data analyses; preparing signal assessment, tracking and validation documents; lead cross functional teams to assess and interpret safety signals; preparing action and communication plans (written and verbal) to mitigate/manage product risks in collaboration with key stakeholders
* Lead multidisciplinary Safety Review Committees (SRC) or equivalent, whose responsibilities include safety surveillance (signal detection and evaluation), risk management planning, and making recommendations regarding communication plan and labeling, as appropriate
* Lead safety reviews for DMC meetings for assigned products in partnership with cross-functional stakeholders
* Lead proactive and ongoing assessment of pre-clinical, clinical, scientific literature, and other data to inform safety strategy and support positive benefit-risk profile for assigned programs in collaboration with key stakeholders
* Provide pharmacovigilance expertise to support full lifecycle drug development and study execution; represent Pharmacovigilance group at study execution and strategic forums
* Responsible for developing expertise regarding relevant drug products in the immunology space, with continuous knowledge acquisition and education regarding current safety matters
* Review of individual and aggregate AEs, preparing safety reports, and communicating changes in the product risk profile to internal and external stakeholders.
* Perform individual case safety report (ICSR) medical review to ensure accurate medical coding, seriousness, expectedness and company causality assessment, ensure appropriate medical interpretation, completeness, and accuracy of information, review and draft queries, and prepare or review the analysis of similar events (AOSE) as required
* Responsible for the identification, evaluation, validation, and communication of possible adverse event trends for products including individual and aggregate data analyses
* Collaborate with cross functional team, including Clinical Development, Regulatory Affairs, Biostatistics, and other functional areas to design, evaluate, implement, and oversee safety risk mitigation strategies (REMS, Risk Management Plan, Post-Approval Safety Surveillance) to ensure safe and appropriate use of company products in compliance with global regulatory requirements
* Address internal/external safety-related requests, including questions from Health Authorities and/or Ethics Committees (both written and verbal)
* Author and/or review pre- and post-marketing aggregate safety reports including DSUR, 6-monthly line listing reports, PSUR, PBRER, PADER, IND Annual Reports
* Review medical/scientific literature to support signal detection activities and aggregate reporting for products
* Contribute to the development and review of clinical, regulatory, and scientific documents including protocols, informed consent forms, clinical study reports, manuscripts/journal articles, case report forms, statistical analysis plans, integrated summaries of safety (ISS), New Drug or Biologic License Applications (NDA/BLA), and/or other documents as needed, ensuring safety content is harmonized where applicable
* Lead and/or contribute to the development and maintenance of Reference Safety Information (RSI) including Company Core Data Sheet (CCDS), Company Core Safety Information (CCSI), Investigator Brochure (IB), and/or other product labeling.
* Develop or support development of standard operating procedures (SOPs) and/or other process related documents e.g. Safety Management Plans, Work Instructions
* Active participant in inspection readiness activities, internal audits, and external inspections
* Develop training materials and conduct training on PV related content, including presentations at Investigator Meetings or Site Initiation Visits, as needed
* Contribute to vendor governance activities and oversight of key performance indicators
* Oversight and support for MedDRA and WHODrug coding and SAE reconciliation activities
* Participate in the development of PV organizational strategy, goals, and objectives and assist with implementation and training to support department goals and initiatives
* Maintain knowledge of new PV/safety regulations and guidance from regulatory authorities, ACELYRIN SOPs, and quality standards
* Maintain knowledge of disease indications for assigned investigational and/or marketed products
* Support hiring, orientation, management, mentorship, and development of PV team
* Support organizational leadership in assigned activities and initiatives
* Other duties, as assigned

Minimum Qualifications (Education & Experience)

* MD required, Board certification preferred
* 3+ years of pharmacovigilance experience; other relevant experience may be considered.
* Experience as safety lead for asset/approved drug product e.g. Global Safety Lead with responsibility for PV documents including but not limited to DSUR/PBRER; IB and ICF safety sections; risk management strategies and plans
* Oversight experience of global medical safety activities including asset / approved product level safety governance, operations and risk management strategies in pre and post marketing environments.
* Demonstrated knowledge of global PV 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 environments
* Working knowledge of industry standard safety databases (ARGUS and ARISg) and other electronic data capture systems
* Knowledge of MedDRA dictionary with relevance to adverse event coding
* Excellent knowledge of drug development process, including clinical trial methodology, medical terminology and general principles of clinical assessment of AEs
* Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data and developing risk management/mitigation strategies
* Experienced in supporting PV audits and/or health authority inspections
* Ability to navigate 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
* Demonstrates leadership and interacts collaboratively and effectively in a team environment (e.g. Clinical Development, Biometrics, Clinical Operations, Regulatory Affairs, Medical Affairs) and with external vendors and stakeholders
* Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities.
* Excellent communication skills and ability to influence across multiple functions.
* International/domestic travel may be required

Essential behaviors and ways of working:

* Ability to navigate 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
* Excellent communication, interpersonal, and writing skills, including ability to work effectively cross-culturally and cross-functionally with internal and external stakeholders
* Strong organizational and project management skills
* Ability to function and communicate cross functionally and work with global teams
* Good culture fit with ACELYRIN's Core Values:
* Courage: Quickly solving challenging issues
* Compassion: Putting patients first to dramatically transform their lives
* Collaboration: Building strong, innovative and diverse teams focused on developing therapeutics through efficient win/win partnerships
* Innovation: A different kind of biopharma redefining what is possible
* A Sense of Urgency: Accelerating development and commercialization of transformative medicines for serious diseases

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

ACELYRIN, INC, does not discriminate on the basis of race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. Any individual, who, because of a disability, needs accommodation or assistance in completing this application or at any time during the application process, should contact the Human Resources Department.

Candidates will be required to show proof of being fully vaccinated against COVID-19 upon commencing employment. Reasonable accommodations will be considered on a case-by-case basis for exemptions to this requirement in accordance with applicable law.

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