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Braveheart Bio · 2 days ago

Senior Director, Pharmacovigilance

United States

Full-time

Remote

Director/Executive

$325K/yr - $376K/yr

12+ years exp

Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease. The Senior Director, Pharmacovigilance will lead the global PV strategy and ensure compliance with regulatory safety obligations, collaborating closely with various departments to prepare for global Phase 3 execution.

BiotechnologyLife ScienceTherapeutics

Hiring Manager

Erica Arkin

Responsibilities

Lead strategic and operational activities for the PV department

Responsible for all PV operations and compliance aspects of all Braveheart's products throughout the product lifecycle

Build and oversee PV infrastructure, PV systems and PV processes to support the growing volume and complexity of safety data generated by our global Phase 3 program and partnered studies

Oversee the process for ICSR collection, processing, reconciliation, and reporting, including associated quality activities to ensure regulatory timelines and global standards are met

Serve as the drug safety expert for regulatory submissions, leading PV contributions to relevant sections and responses to queries from regulatory authorities

Develop and oversee the process for signal detection, evaluation, and management

Provide PV operational expertise in the development of RMPs, aggregate safety reports, REMS, and other safety deliverables

Provide review, analysis and medical guidance during the case handling and reporting process for serious AEs (SAEs) received for the Braveheart investigational products

Contribute to safety sections of clinical study documents including Study Protocols, Informed Consent Forms (ICF), Clinical Study Reports (CSR), IB Reference Safety Information (RSI), and other relevant documents

Lead vendor selection and provide vendor oversight for all outsourced PV activities, including establishing and monitoring key quality and compliance metrics

Responsible for the development and maintenance of Safety Management Plans and PV Agreement/Safety Data Exchange Agreement with license partners and distributors

Qualification

Pharmacovigilance operationsDrug development experienceGlobal regulations knowledgeSafety section writingInterpersonal skillsProactive mindsetPMP certificationAdvanced degreeTeam-oriented approachAdaptability

Required

Degree in Health Care is required (e.g., MD, DO, PhD, NP, Pharm D)

At least 12 years of experience in drug development at global pharmaceutical or biotechnology companies, including at least 8 years of experience in PV operations in the clinical trial and post-marketing environments

Strong knowledge of global regulations governing pharmacovigilance in the pharmaceutical industry and Research & Development processes

Experience in writing safety sections (2.7.4, ISS, narratives) of marketing applications, and successfully defending contents to Health Authorities

Strong interpersonal and communication skills for bridging between scientific and business participants, for negotiating timelines and for effective international collaboration

Strong written and verbal communication skills with a collaborative, team-oriented approach

Ability to thrive in a fast-paced, dynamic environment and remain comfortable with change and ambiguity

Flexible, proactive, and hands-on mindset with a roll-up-your-sleeves, can-do attitude

Preferred

Advanced degree (MBA, MS, PhD) will be considered in lieu of industry work experience

PMP certification

Expertise gained from working directly in an R&D functional domain (e.g., Research, Clinical, CMC, or Regulatory Affairs), combined with global team exposure and prior Project/Program Leadership experience, is highly desirable