Pharmacovigilance Scientist

Stoke Therapeutics•Bedford, MA

2d•Hybrid

About The Position

Stoke Therapeutics is a biotechnology company focused on RNA medicine to restore protein expression. They are developing antisense oligonucleotides (ASOs) to selectively restore naturally occurring protein levels. Their first medicine, zorevunersen, is in Phase 3 for Dravet syndrome and has a strategic collaboration with Biogen. STK-002 is an ASO in clinical development for autosomal dominant optic atrophy (ADOA) and has received orphan drug designation. Stoke is also researching Syngap1 in collaboration with Acadia Pharmaceuticals. The company's initial focus is on central nervous system and eye diseases caused by haploinsufficiency, with potential applications in other areas. This newly created Pharmacovigilance Scientist role is crucial for supporting ongoing clinical development and an upcoming NDA submission for a first-in-class ASO therapy. The position offers a significant opportunity to shape the scientific infrastructure of the PV department during a critical growth phase. The PV Scientist will be responsible for overall PV science support, collaborating with Safety Physicians and cross-functional teams to lead signal detection activities within the company's safety governance model. The ideal candidate will possess deep PV science experience and contribute to clinical and regulatory workstreams, playing a key role in enhancing PV processes and procedures, particularly for the post-approval setting. This role is best suited for an individual comfortable in a small, fast-paced biotech environment.

Requirements

Bachelor’s degree in life sciences/pharmacy/nursing degree or related field; advanced degree (MS, PharmD or equivalent) preferred
Minimum of 10 years of proven pharmacovigilance experience including a combination of PV Operations and PV Scientist-related experience
Proficiency with signal detection tools and methods; demonstrated ability to synthesize complex safety data into actionable safety intelligence that supports the medical judgment of the safety physician/cross-functional team and informs benefit-risk decision-making.
Experience with safety surveillance and signal detection processes in early to late phase development clinical trials and postmarketing safety surveillance.
General knowledge and understanding of US and EU PV requirements, e.g. US Code of Federal (CFR) regulations, European Union (EU) Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines
Experience and extensive working knowledge of MedDRA and proprietary safety databases, PV processes for individual case medical review, signal detection and evaluation, aggregate data assembly, review and reporting, as well as clinical study safety management
Experience with compilation, writing and reviewing safety documents such as DSURs, IB, PBRERs/PADERs, responses to Health Authority requests, submission documents and safety labels
Previous NDA/BLA/MAA experience including contributing to the preparation and authoring of the safety related aspects of the Common Technical Document
Strong relationship building skills, with ability to interact effectively in a multifunctional, multicultural, growing organization
Strategic thinking, strong organizational and analytic skills, project management, excellent verbal, written communication skills, attention to detail

Responsibilities

Leads PV Scientist activities of cross-functional project teams for developmental compounds and/or marketed products at Stoke.
Works in collaboration with the Safety Physician/PV Leadership to develop, maintain, oversee, and execute the comprehensive safety surveillance and signal detection plan for assigned products.
Support benefit-risk assessments; author or contribute to signal evaluation reports.
Author and contribute to safety sections and other relevant content of Investigator Brochures, Protocols, Informed Consents and Clinical Study Reports.
Leads the collaboration with PV and Clinical representatives, and authors the Reference Safety Information (RSI) for assigned products based on the developed benefit-risk profile.
Authors/provides strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to processes and timelines.
Authors/provides strategic leadership to regulatory submissions for new products, formulations or indications (NDA/BLA, MAA), in partnership with the PV leadership and other functional experts.
Leads PV Scientist activities of cross-functional project teams for developmental compounds and/or marketed products.