Associate Director, Pharmacovigilance Scientist
Sionna Therapeutics, Boston, MA, United States
Sionna Therapeutics is a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for CF by developing novel medicines that normalize the function of the CFTR protein. Sionna’s goal is to deliver differentiated medicines for people living with CF that can restore their CFTR function to as close to normal as possible by directly stabilizing CFTR’s nucleotide‑binding domain 1 (NBD1), which the company believes is central to potentially unlocking meaningful improvements in clinical outcomes and quality of life for people with CF. Leveraging over a decade of the co‑founders’ extensive research on NBD1, the company is advancing a pipeline of novel small molecules engineered to correct the defects caused by the F508del genetic mutation, which resides in NBD1. Sionna is also developing a portfolio of complementary CFTR modulators that are designed to work synergistically with its NBD1 stabilizers to improve CFTR function.
Position Summary: Sionna Therapeutics is seeking an Associate Director of Pharmacovigilance (AD PV) to join a collaborative, mission‑driven, and high‑performing biotech team. This individual will play a critical role in managing and developing Sionna’s pharmacovigilance function. The AD PV Scientist will ensure compliance with global regulatory requirements, oversee PV processes related to clinical‑stage assets, and contribute to the development of a robust safety infrastructure suitable for a growing biotech environment. This is a hands‑on role requiring both strategic oversight and deep operational involvement in PV processes.
The person in this role reports to the Senior Director of Clinical Development/Global Safety Officer (GSO) and will also work closely with the Chief Medical Officer and Senior Pharmacovigilance consultant. The AD PV Scientist will lead or contribute to key PV deliverables and activities associated with signal detection and management, benefit‑risk evaluations and regulatory and aggregate safety reporting processes, PV SOP development and management, and oversight of the PV vendor and Clinical CRO safety activities.
Effective communication skills will be key as this role provides an excellent opportunity for close collaboration with colleagues from functions including Clinical Development, Clinical Operations, Regulatory Affairs, and Medical Affairs, among others. This role will also contribute to safety governance and represent Pharmacovigilance in cross‑functional decision‑making forums. A track record of sound clinical and scientific decision making is also essential, along with a desire to help grow and shape Pharmacovigilance at Sionna.
The position is based in the greater Boston area, with the opportunity to craft a flexible hybrid work schedule including in‑person and remote work as part of Sionna’s Flexible First workforce strategy.
Responsibilities: PV Leadership and Strategy
Collaborate with GSO on the design, implementation, and continuous improvement of the company’s pharmacovigilance system
Develop and/or contribute to PV strategies aligned with clinical development plans and regulatory expectations
Serve as the internal subject matter expert for PV matters with special emphasis on PV operations and procedures
Pharmacovigilance Operations and Vendor Oversight
Oversee the PV vendors tasked with case processing and timely submission of expedited reports (e.g. SUSARs) to global health authorities
Collaborate with PV vendors in their literature surveillance processes, including reviewing output of routine literature reviews alongside GSO
Contribute to aggregate reporting activities (e.g., DSURs) including data analysis and authoring support
Oversee PV vendor in work related to Argus safety database including timely set up of future studies within Argus, integration with global health authority electronic gateways, and other database updates requiring Sionna’s input
Review PV vendor performance with regards to key performance indicators (KPIs) and metrics for PV operations (e.g., case processing timelines, reporting compliance)
Ensure inspection readiness of PV operations, including documentation, audit trails, and training records
Lead signal detection and evaluation activities using qualitative and quantitative methods
Conduct periodic safety data review and trend analysis
Author safety sections of regulatory submissions
Support preparation of data presentations and conduct of Sionna Safety Monitoring Team meetings
Clinical Development Support
Provide safety input into clinical trial protocols, investigator brochures, and informed consent documents
Participate in Safety Review Committees and Data Monitoring Committees
Collaborate with Clinical Operations to ensure alignment of safety data collection and reporting
Compliance & Quality
Develop, review, and maintain PV SOPs, work instructions, and related documentation
Ensure compliance with global regulations (FDA, EMA, ICH, etc.) and internal quality standards
Support internal audits, vendor audits, and regulatory inspections
Qualifications:
Advanced degree (e.g., RN, PharmD, PhD, MD, MPH, NP, DVM)
4+ years of relevant pharmacovigilance experience, including experience supporting clinical development programs
Deep understanding of global PV regulations (FDA, EMA, ICH guidelines)
Hands‑on experience with case processing and medical review, safety databases (e.g., Argus), MedDRA coding and WHO Drug Dictionaries, expedited reporting (SUSARs, ICSR), and aggregate safety reports (e.g. DSURs)
Experience with safety data reconciliation and signal detection tools
Sound clinical acumen and decision making
Ability to review, synthesize and analyze and communicate (verbally and in writing) complex safety data and clinical/pharmaceutical information
Demonstrated leadership and ability to influence cross‑functional teams and drive safety strategy
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Position Summary: Sionna Therapeutics is seeking an Associate Director of Pharmacovigilance (AD PV) to join a collaborative, mission‑driven, and high‑performing biotech team. This individual will play a critical role in managing and developing Sionna’s pharmacovigilance function. The AD PV Scientist will ensure compliance with global regulatory requirements, oversee PV processes related to clinical‑stage assets, and contribute to the development of a robust safety infrastructure suitable for a growing biotech environment. This is a hands‑on role requiring both strategic oversight and deep operational involvement in PV processes.
The person in this role reports to the Senior Director of Clinical Development/Global Safety Officer (GSO) and will also work closely with the Chief Medical Officer and Senior Pharmacovigilance consultant. The AD PV Scientist will lead or contribute to key PV deliverables and activities associated with signal detection and management, benefit‑risk evaluations and regulatory and aggregate safety reporting processes, PV SOP development and management, and oversight of the PV vendor and Clinical CRO safety activities.
Effective communication skills will be key as this role provides an excellent opportunity for close collaboration with colleagues from functions including Clinical Development, Clinical Operations, Regulatory Affairs, and Medical Affairs, among others. This role will also contribute to safety governance and represent Pharmacovigilance in cross‑functional decision‑making forums. A track record of sound clinical and scientific decision making is also essential, along with a desire to help grow and shape Pharmacovigilance at Sionna.
The position is based in the greater Boston area, with the opportunity to craft a flexible hybrid work schedule including in‑person and remote work as part of Sionna’s Flexible First workforce strategy.
Responsibilities: PV Leadership and Strategy
Collaborate with GSO on the design, implementation, and continuous improvement of the company’s pharmacovigilance system
Develop and/or contribute to PV strategies aligned with clinical development plans and regulatory expectations
Serve as the internal subject matter expert for PV matters with special emphasis on PV operations and procedures
Pharmacovigilance Operations and Vendor Oversight
Oversee the PV vendors tasked with case processing and timely submission of expedited reports (e.g. SUSARs) to global health authorities
Collaborate with PV vendors in their literature surveillance processes, including reviewing output of routine literature reviews alongside GSO
Contribute to aggregate reporting activities (e.g., DSURs) including data analysis and authoring support
Oversee PV vendor in work related to Argus safety database including timely set up of future studies within Argus, integration with global health authority electronic gateways, and other database updates requiring Sionna’s input
Review PV vendor performance with regards to key performance indicators (KPIs) and metrics for PV operations (e.g., case processing timelines, reporting compliance)
Ensure inspection readiness of PV operations, including documentation, audit trails, and training records
Lead signal detection and evaluation activities using qualitative and quantitative methods
Conduct periodic safety data review and trend analysis
Author safety sections of regulatory submissions
Support preparation of data presentations and conduct of Sionna Safety Monitoring Team meetings
Clinical Development Support
Provide safety input into clinical trial protocols, investigator brochures, and informed consent documents
Participate in Safety Review Committees and Data Monitoring Committees
Collaborate with Clinical Operations to ensure alignment of safety data collection and reporting
Compliance & Quality
Develop, review, and maintain PV SOPs, work instructions, and related documentation
Ensure compliance with global regulations (FDA, EMA, ICH, etc.) and internal quality standards
Support internal audits, vendor audits, and regulatory inspections
Qualifications:
Advanced degree (e.g., RN, PharmD, PhD, MD, MPH, NP, DVM)
4+ years of relevant pharmacovigilance experience, including experience supporting clinical development programs
Deep understanding of global PV regulations (FDA, EMA, ICH guidelines)
Hands‑on experience with case processing and medical review, safety databases (e.g., Argus), MedDRA coding and WHO Drug Dictionaries, expedited reporting (SUSARs, ICSR), and aggregate safety reports (e.g. DSURs)
Experience with safety data reconciliation and signal detection tools
Sound clinical acumen and decision making
Ability to review, synthesize and analyze and communicate (verbally and in writing) complex safety data and clinical/pharmaceutical information
Demonstrated leadership and ability to influence cross‑functional teams and drive safety strategy
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