Pharmacovigilance Scientist

Position Purpose:

We are building our Pharmacovigilance department in support of ongoing clinical development activities and NDA submission for a first-in-class antisense oligonucleotide (ASO) therapy in a rare pediatric neurological disease. The PV Scientist is a newly created role and a genuine opportunity to shape the scientific infrastructure of PV department at a critical inflection point.  

The PV Scientist is accountable for overall PV science support for pharmacovigilance department at Stoke, which includes working in collaboration with the Safety Physician(s) and cross-functional teams to lead signal detection activities conducted in the safety governance model within the company. The ideal candidate will have deep PV science experience and will contribute across clinical and regulatory workstreams and play a critical role in further developing and enhancing PV processes and procedures relative to the PV scientist role in the post-approval setting.   The role is best suited for someone who is comfortable operating in a small, fast-paced biotech environment.  This position reports to PV Leadership.  

Key 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 

Required Skills & Experience: 

•    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

Location(s): 
Stoke is located in Bedford, MA, and will be moving to a new location in Waltham, MA by the end of 2026. This position is a hybrid position currently based in Bedford and will later be based in Waltham. 

Travel:
This position will require approximately 10% travel. 

Compensation & Benefits:
At Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program. 

The anticipated salary range for this role is $237,000 - $270,000. The final offer will be determined based on a variety of factors, including role scope, experience and qualifications, education, market benchmarks, internal equity, and geographic location. In addition to base salary, Stoke offers an annual bonus and equity participation.

Our benefits package includes medical, dental and vision insurance; life, long- and short-term disability insurance; paid parental leave; a 401K plan with company match, unlimited vacation time, tuition assistance and participation in our Employee Stock Purchase Program (ESPP).