Vice President Drug Safety and Pharmacovigilance at Vor Bio

Boston, Massachusetts, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Autoimmune DiseaseIndustries

Requirements

Advanced degree in pharmacy, medicine, life sciences, or a related field (e.g., PharmD, MD, PhD)
15+ years of experience in pharmacovigilance, with at least 5 years in a leadership role
In-depth knowledge of global pharmacovigilance regulations and best practices
Expertise in safety surveillance, risk management, regulatory compliance, and team leadership
Strong analytical thinking, communication, and organizational skills
Ability to manage complex projects and teams
Certification in pharmacovigilance or drug safety (preferred)
Experience with regulatory inspections and audits
Ability to work in a fast-paced environment and adapt to changing priorities
Strong problem-solving and decision-making skills

Responsibilities

Develop and implement the overall pharmacovigilance strategy for the organization
Provide expert guidance on safety risk management and regulatory compliance
Oversee the collection, evaluation, and reporting of adverse events for all products
Lead signal detection, risk assessment, and mitigation activities
Ensure timely submission of safety reports to regulatory authorities
Maintain up-to-date knowledge of global pharmacovigilance regulations and best practices
Manage, mentor, and develop a high-performing pharmacovigilance team
Allocate resources effectively to meet project and compliance deadlines
Foster a culture of continuous improvement and professional growth
Work closely with clinical development, medical affairs, regulatory affairs, and commercial teams
Provide safety input for clinical trial protocols, informed consent forms, and product labeling
Support due diligence and integration activities for business development initiatives

Skills

Key technologies and capabilities for this role

PharmacovigilanceDrug SafetyRisk AssessmentRegulatory CompliancePatient SafetyPost-Marketing SurveillanceClinical DevelopmentLeadership

Questions & Answers

Common questions about this position

What are the key responsibilities of the Vice President of Pharmacovigilance?

The role involves developing pharmacovigilance strategy, overseeing safety surveillance and risk management, ensuring regulatory compliance, and leading team development.

What is the salary or compensation for this position?

This information is not specified in the job description.

Is this role remote or does it require office presence?

This information is not specified in the job description.

What is the company culture like at Vor Bio?

Vor Bio fosters a culture of belonging where every voice is heard, and the shared mission unites teams across functions and geographies, with emphasis on impact, growth, innovation, and belonging.

What makes a strong candidate for this VP role?

A strong candidate will have scientific expertise, deep regulatory knowledge in global pharmacovigilance (e.g., FDA, EMA, ICH), and proven leadership skills to manage teams and cross-functional collaboration.

Vor Bio

Develops targeted therapies for blood cancers

About Vor Bio

Vor Biopharma focuses on developing treatments for blood cancers, particularly Acute Myeloid Leukemia (AML). Their approach is designed to protect healthy cells while specifically targeting and eliminating cancerous cells. This method aims to improve the effectiveness of blood cancer treatments. Vor Biopharma serves patients with blood cancers, their caregivers, and medical professionals in hospitals and oncology centers. What sets Vor Biopharma apart from competitors is their strong emphasis on research and development, investing significantly in scientific research to create a proprietary platform and pipeline of therapies. They generate revenue through partnerships with other pharmaceutical companies and licensing agreements, with the goal of commercializing their therapies after obtaining regulatory approval. The company's mission is to transform the treatment landscape for blood cancers by providing innovative therapies that prioritize patient safety and efficacy.

Cambridge, MassachusettsHeadquarters

2015Year Founded

$147.9MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

51-200Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Paid Vacation

Parental Leave

401(k) Retirement Plan

401(k) Company Match

Commuter Benefits

Risks

Significant YTD price decline of -62.76% may affect investor confidence.

Key clinical trial data updates are not expected until 2025, causing uncertainty.

Increased competition from companies like Editas Medicine poses potential conflicts.

Differentiation

Vor Bio focuses on protecting healthy cells while targeting cancerous ones.

The company specializes in innovative treatments for blood cancers like AML.

Vor Bio's approach aligns with the rise of personalized medicine.

Upsides

Recent $55.6M funding supports clinical trials and extends cash runway to 2025.

FDA's acceptance of gene therapies may ease approval for Vor Bio's treatments.

Advancements in CRISPR technology enhance precision of Vor Bio's gene editing.

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