[Remote] Manager / Senior Manager, Drug Safety Operations at Abata Therapeutics

Remote

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

Bachelor’s degree in life sciences or related field required; advanced degree preferred
Minimum 7+ years in drug safety/pharmacovigilance operations within biotech or pharmaceutical industry
Proven experience managing safety vendors and overseeing case processing activities
Hands-on experience with pharmacovigilance agreements and safety database management
Strong knowledge of global PV regulations and GVP guidelines
Excellent organizational, communication, and vendor management skills
Ability to thrive in a fast-paced, start-up environment
Experience with pharmacovigilance-related quality events including change control, deviations, and CAPA management and compliance reports is preferred

Responsibilities

Manage and oversee safety vendors responsible for case processing and related pharmacovigilance activities
Ensure vendor compliance with contractual obligations, timelines, and quality standards
Oversee case processing activities, including intake, triage, and timely reporting of adverse events
Maintain and monitor trackers for lab values and other safety-related data to ensure accurate and timely updates
Manage pharmacovigilance agreements (PVAs) with partners and ensure alignment with regulatory requirements
Oversee the configuration, maintenance, and quality control of the safety database
Ensure accurate data entry, reconciliation with clinical databases, and timely generation of safety reports
Build strong relationships with internal stakeholders (clinical operations, regulatory, medical) and external partners
Provide operational expertise during audits and inspections
Ensure adherence to global PV regulations (FDA, EMA, ICH) and company SOPs
Manage pharmacovigilance-related quality events including change control, deviations, and CAPAs
Manage PV-related Key Performance Indicators (KPI) metrics system and reporting methods

Skills

Key technologies and capabilities for this role

PharmacovigilanceDrug Safety OperationsVendor ManagementRegulatory ComplianceGlobal Safety RegulationsCase ProcessingChange ControlDeviationsCAPA ManagementCompliance Reports

Questions & Answers

Common questions about this position

Is remote work an option for this position?

Yes, the company is open to you working remotely.

What is the salary range for the Manager / Senior Manager, Drug Safety Operations role?

This information is not specified in the job description.

What key skills and experience are required for this role?

The role requires experience managing vendor relationships, ensuring compliance with global safety regulations like FDA, EMA, and ICH, and handling pharmacovigilance processes including case processing, safety database management, and quality events such as change control, deviations, and CAPA.

What is the company culture like at Dianthus Therapeutics?

The company is building a culture of individuals who hold core principles at the center of operations, with the goal to elevate the care of patients’ lives, and features a growing pharmacovigilance team working closely with cross-functional teams.

What makes a strong candidate for this Drug Safety Operations role?

Strong candidates will have experience in vendor oversight, pharmacovigilance operations like case processing and safety database management, compliance with global regulations, and handling quality events such as deviations and CAPA.

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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