Vice President, Head of Pharmacovigilance

Remote

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Biologics, Drug DevelopmentIndustries

Requirements

Candidates must possess an MD degree and at least 15 years of experience in pharmacovigilance. A strong understanding of global regulatory requirements, including FDA, EMA, MHRA, and PMDA, is essential. Experience in leading drug safety strategy and operations, as well as managing pharmacovigilance teams, is required.

Responsibilities

The Vice President, Head of Pharmacovigilance will lead the company's global drug safety strategy and operations, ensuring compliance with all relevant regulatory requirements. This includes developing pharmacovigilance policies, overseeing adverse event reporting, risk management plans, and aggregate safety analysis. The role involves collaborating with cross-functional teams, representing the company to health authorities, and contributing to regulatory submissions and safety content review for publications. Additionally, the position is responsible for building and leading a high-performing pharmacovigilance team.

Skills

Pharmacovigilance

Drug Safety

Regulatory Compliance

Risk Management

Clinical Development

Medical Affairs

Biologics

Antibody Engineering

Leadership

Strategy

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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