[Remote] Senior Manager, Pharmacovigilance at Abata Therapeutics

Remote

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Autoimmune DiseasesIndustries

Requirements

PharmD or RN degree required
Experience in pharmacovigilance or in clinical development within biotech or pharmaceutical industry
Experience reviewing adverse events, safety signals
Experience coordinating/contributing to Safety Review Committee (SRC) and Drug Safety Monitoring Boards (DSMB) meetings

Responsibilities

Oversee pharmacovigilance activities for assigned clinical programs, ensuring alignment with global regulatory requirements and internal SOPs
Review, evaluate, and provide managerial oversight of adverse event (AE) reports, including serious adverse events (SAEs), ensuring accurate assessment and timely submission to regulatory authorities and ethics committees
Ensure quality and accuracy of safety data review within the safety database and direct reconciliation efforts with clinical databases to maintain data integrity
Contribute to the development of safety sections within clinical documents, including protocols, investigator brochures, and clinical study reports
Manage and oversee the scheduling, planning, and facilitation of DSMB and SRC meetings, including preparation of agendas, meeting materials, guided discussions, documentation of minutes, and follow-up on action items
Contribute strategically to the preparation of aggregate safety reports such as the DSUR
Partner with safety physicians on signal detection, emerging safety issues, risk assessments, and benefit–risk evaluations
Serve as a subject matter expert to internal stakeholders and external partners on safety-related topics, providing guidance and ensuring consistent communication
Ensure organizational compliance with global pharmacovigilance regulations (FDA, EMA, ICH) and company policies
Manage and oversee pharmacovigilance-related quality events, including change controls, deviations, and CAPAs, ensuring timely resolution and documentation
Supervise and ensure accurate documentation of DSMB and SRC meetings and maintain records within designated systems and repositories

Skills

Pharmacovigilance

Adverse Event Review

Safety Signal Detection

Regulatory Compliance

Safety Review Committee

Drug Safety Monitoring Board

Clinical Trial Safety

Abata Therapeutics

Develops therapies for autoimmune diseases

About Abata Therapeutics

Abata Therapeutics develops therapies for autoimmune diseases, focusing on type 1 diabetes. Their main product, ABA 201, is a Treg cell therapy aimed at patients with some remaining beta cell function. This therapy works by utilizing regulatory T cells to improve patient outcomes. Unlike many competitors, Abata targets a specific niche within the autoimmune disease market and collaborates with partners like ElevateBio for process development and manufacturing. The company's goal is to transform treatment options for autoimmune diseases through advanced research and development.

Cambridge, MassachusettsHeadquarters

2021Year Founded

$184.8MTotal Funding

EARLY_VCCompany Stage

BiotechnologyIndustries

11-50Employees

Risks

Intensifying competition from companies like Sangamo Therapeutics may impact Abata's market share.

Stringent FDA scrutiny on manufacturing could delay Abata's clinical trials.

Rising clinical trial costs pose financial risks to Abata's pipeline progression.

Differentiation

Abata focuses on Treg cell therapies for autoimmune diseases like MS and diabetes.

Their lead product, ABA 201, targets type 1 diabetes with remaining beta cell function.

Abata's strategic partnership with ElevateBio enhances their manufacturing capabilities.

Upsides

Recent investment from Bristol Myers Squibb boosts Abata's Treg therapy pipeline development.

FDA's accelerated approval pathways may expedite Abata's clinical trials.

Growing autoimmune disease prevalence increases demand for Abata's innovative treatments.

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