Director, Pharmacovigilance Scientist at BlueRock Therapeutics

Cambridge, Massachusetts, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Pharmaceuticals, Cell TherapyIndustries

Requirements

Advanced degree in Pharmacy, Nursing, Epidemiology, Biosciences, or related healthcare discipline
8+ years of pharmaceutical industry experience, with at least 6 years in pharmacovigilance
Demonstrated experience as the PV lead for global clinical programs across multiple phases
Strong expertise in safety data evaluation, signal detection, aggregate reporting, and regulatory submissions
Proven ability to represent PV in cross-functional and external regulatory settings
Experience collaborating with and influencing senior cross-functional stakeholders in a matrix environment
Excellent communication, organizational, and leadership skills
Ability to manage competing priorities in a fast-paced, dynamic environment

Responsibilities

Serve as the PV lead for assigned programs, accountable for end-to-end safety deliverables including signal detection, aggregate reporting, and risk management planning
Represent PV on program-level governance committees and cross-functional teams, ensuring clear role delineation between PV and Clinical Development
Lead the preparation and PV input into protocols, Investigator Brochures, ICFs, SAPs, CSRs, regulatory submissions, and labeling documents for assigned programs
Develop and maintain program-level PV strategies aligned with global regulatory requirements and company objectives
Lead PV contributions to regulatory authority interactions and inspection readiness activities for assigned programs
Partner with CROs and vendors to ensure timely and compliant PV deliverables; monitor performance and escalate issues as needed
Contribute to departmental process improvement and knowledge-sharing initiatives
Mentor junior staff or consultants supporting PV deliverables

Skills

Pharmacovigilance

Drug Safety

Risk Management

Signal Detection

Adverse Event Reporting

Regulatory Compliance

Clinical Development

Neurology

Cell Therapy

BlueRock Therapeutics

Develops advanced cellular therapies for diseases

About BlueRock Therapeutics

BlueRock Therapeutics develops advanced cellular therapies using a unique cell gene platform that directs cellular differentiation and genetically engineers cells. This technology allows them to create new types of medicines aimed at treating complex diseases in areas such as neurology, cardiology, and immunology. Their products work by transforming cells to target specific medical conditions, including neurodegenerative diseases, heart failure, and immune disorders. Unlike many competitors, BlueRock focuses on a specialized approach within the rapidly growing field of regenerative medicine, emphasizing strategic partnerships and research and development to advance their therapies. The company's goal is to address challenging medical conditions through innovative cellular treatments and to generate revenue through collaborations, licensing agreements, and eventual commercialization of their therapies.

Cambridge, MassachusettsHeadquarters

2016Year Founded

$218.9MTotal Funding

ACQUISITIONCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Remote Work Options

Hybrid Work Options

Risks

Competition from established firms like Johnson & Johnson may overshadow BlueRock's innovations.

Reliance on strategic partnerships poses risks if partners shift focus or resources.

Regulatory hurdles could delay product launches, impacting revenue and market position.

Differentiation

BlueRock uses iPSC technology to create novel cellular therapies for complex diseases.

Their strategic partnerships enhance R&D capabilities and expand therapeutic applications.

Focus on neurology, cardiology, and immunology addresses challenging medical conditions.

Upsides

FDA RMAT designation for bemdaneprocel accelerates market entry for Parkinson's therapy.

Successful Phase I trial of bemdaneprocel boosts investor confidence and funding potential.

Collaboration with bit.bio enhances discovery and development of new cell therapies.

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