VP of Drug Safety/Pharmacovigilance

Compass Therapeutics•Boston, MA

3d•$325,000 - $450,000•Hybrid

About The Position

Compass Therapeutics, Inc. is seeking a highly motivated and hands-on VP of Pharmacovigilance to join their Clinical Development team. The ideal candidate will have a proven track-record of Pharmacovigilance leadership and risk management, and desires to be part of a fast-paced and collaborative team. This position reports to the Chief Medical Officer and is onsite 4 days/week in Brighton, MA. The company is an oncology-focused biopharmaceutical company discovering and developing proprietary antibody-based therapeutics. They are at an exciting inflection point as they build out a commercial organization to support their first product launch.

Requirements

MD or an equivalent advanced degree required
10+ years of relevant clinical drug safety/pharmacovigilance experience in the biotech or pharmaceutical industry is required
Significant experience in broader pharmacovigilance/safety risk management in key leadership positions of responsibility within a pharmaceutical or biotech environment (industry, CRO)
Expertise in pre- and post-approval pharmacovigilance/safety risk management process and procedures
Thorough understanding of the drug development process and context applicable to safety surveillance activities, i.e. signal detection, evaluation, aggregate data analysis, and interpretation in clinical trials
Advanced working knowledge of and experience following FDA and ICH guidelines, including experience working on an IND or BLA
Knowledge of MedDRA terminology and its application
Proven experience working within a cross-functional team environment, ability to work and mentor in a fast-paced and collaborative environment
Comfortable with balancing multiple project objectives simultaneously
Ability to assimilate clinical data and through comprehensive analysis/review and assessments
3+ years of vendor oversight experience overseeing pharmacovigilance vendor performance
Strong written, verbal, technical communication and presentation skills
Strong analytical ability to synthesize and analyze safety data effectively from various sources
Demonstrated proficiency working with and improving processes within a global Drug Safety Database required, as well as other relevant programs such as Microsoft Office Suite

Nice To Haves

Small company experiences preferred
Oncology experience preferred

Responsibilities

Ensure Compass Clinical Department and Pharmacovigilance objectives are achieved in alignment with corporate milestones, quality standards and applicable regulations
Provide strategic guidance on patient safety, benefit-risk assessment, safety evaluation, and compliance, to inform Compass’ portfolio, Clinical Development, and corporate strategy
Serve as the company's pharmacovigilance subject matter expert, leading patient safety initiatives and maintaining expertise in the evolving global drug safety landscape to identify emerging risks, gaps, and opportunities
Evaluate and optimize existing pharmacovigilance systems, processes, and infrastructure to support commercial readiness; develop post-marketing commercial/medical strategies
Establish and maintain the company’s pharmacovigilance governance framework, including cross-functional safety processes, and oversight of our external vendors (e.g. CRO’s) covering pharmacovigilance and medical risk management activities
Lead cross-functional safety governance and partner with Clinical Development, Regulatory Affairs, Medical Affairs, Quality, Executive Leadership, and external vendors to integrate pharmacovigilance throughout drug development and corporate strategy
Lead interactions with Safety Review Committees and provide input on IDMCs and other safety governance bodies
Provide medical oversight of signal detection, safety evaluation, benefit-risk assessment, and individual case safety review in collaboration with internal team and external service providers
Ensure patient safety by monitoring patient safety profiles to identify and mitigate potential risks associated with Compass drugs; recommend updates to Development Core Safety Information (DCSI)/Reference Safety Information, communicate risks to applicable stakeholders
Provide executive oversight and review of safety-related regulatory submissions, cross functionally collaborating with Clinical, Medical, Quality, and Regulatory, including DSURs, DCSI, Risk Management Plans, Investigator Brochures, Clinical Study Report, Informed Consent Forms (ICFs), protocols, reports, other required safety documentation in accordance with legal requirements, respective SOPs and Health Authority
Review and clean clinical safety in an ongoing compliant manner
Lead pharmacovigilance interactions with regulatory authorities, including responses to safety inquiries, inspections, audits, regulatory commitments, and submission of periodic reporting requirements for FDA, EMA, MHRA, and other applicable agencies
Develop and maintain pharmacovigilance policies, SOPs, templates/forms, SDEAs, safety product/project plans, and quality processes, ensuring compliance by providing training to employees, CROs and investigational site personnel, etc.
Manage pharmacovigilance vendor performance, ensuring high-quality case management, regulatory compliance, inspection readiness, and delivery of contracted services
Mitigate and escalate significant risks related to compliance, quality, budgets, timelines, pharmacovigilance or company milestones; oversee departmental budgets and vendor contracts
Build, mentor, and develop the pharmacovigilance function, fostering a culture of scientific excellence, accountability and continuous improvement

Benefits

Subsidized medical, dental and vision premiums
Health reimbursement arrangement
Flexible spending accounts
Gym membership
Employee assistance program
Life insurance
401(k) and Roth 401(k) programs with a 6% company match
Company parking
Commuter reimbursement
Substantial vacation and leave policies, including summer Fridays, and a winter shut down week
Company-wide training
Tuition and training reimbursement
Recognition awards
Comprehensive performance management