[Remote] Pharmacovigilance Scientist at Abata Therapeutics

Waltham, Massachusetts, United States

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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

Advanced degree in life sciences (e.g., PharmD, PhD) or related field
Minimum of 3 years of experience within the pharmaceutical industry, ideally including drug safety experience
Knowledge of good pharmacovigilance practices, drug safety regulations, and clinical trial processes
Understanding of relevant therapeutic areas, pharmacology, and drug safety regulations
Proficient with safety surveillance systems and tools (e.g., Argus, MedDRA, Veeva Vault)

Responsibilities

Collects, reviews, and analyzes adverse event reports from clinical trials to identify potential safety signals
Supports quality control review of individual case safety reports (ICSRs)
Assists in ongoing safety monitoring activities, including data reconciliation and quality checks to ensure accuracy of safety data
Supports safety data management activities, including case processing, follow-up, and coding of adverse events
Assesses clinical safety data to identify, evaluate, and document adverse events and emerging safety concerns
Contributes to risk-benefit analyses and supports the development of risk mitigation strategies
Supports the preparation and review of pharmacovigilance documents such as Development Safety Update Reports (DSURs), development Risk Management Plans (dRMPs), and relevant sections of clinical trial protocols, IBs and regulatory submissions
Maintains current knowledge of relevant therapeutic areas, pharmacology, and drug safety regulations
Conducts literature reviews and safety signal assessments to inform safety evaluations
Works closely with clinical operations, regulatory affairs, medical affairs, data management, bioinformatics and project management teams to ensure comprehensive safety oversight
Supports compliance with global pharmacovigilance regulations and company safety policies
Supports the communication and oversight of pharmacovigilance and contract research organization vendors
Supports the project management of safety activities such as aggregate reports, safety team meetings, signal evaluations, etc

Skills

Key technologies and capabilities for this role

PharmacovigilanceAdverse Event ReportingSafety Signal DetectionRisk ManagementClinical Trial SafetyRegulatory ComplianceSafety Data AnalysisAggregate Safety Reports

Questions & Answers

Common questions about this position

Is this position remote?

Yes, the position is remote.

What is the salary for the Pharmacovigilance Scientist role?

This information is not specified in the job description.

What key skills are required for this role?

Proficiency with safety surveillance systems and tools such as Argus, MedDRA, and Veeva Vault is required, along with skills in collecting and analyzing adverse event reports, signal detection, risk assessment, and preparing pharmacovigilance documentation.

What is the company culture like at Oruka Therapeutics?

The company seeks to establish an engaged, inclusive, and positive company culture, and is looking for candidates passionate about making a difference and contributing to something bigger.

What makes a strong candidate for this Pharmacovigilance Scientist position?

Top talent who are passionate about making a difference, eager to contribute to an engaged, inclusive company culture, and have expertise in pharmacovigilance activities like safety data management and signal detection.

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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