Director, Pharmacovigilance Scientist

Who is BlueRock?BlueRock Therapeutics LP is a clinical stage cell therapy harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological and ophthalmic diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment of Parkinson’s disease and OpCT-001 for the treatment of primary photoreceptor diseases are clinical stage programs. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves.What Are We Doing?Our foundational science harnesses the ability to create and then direct the differentiation of universal pluripotent stem cells into authentic, functional cells that can be used as allogeneic cellular therapies to treat a broad array of diseases. We can also further engineer these cells, enabling them to produce enzymes, antibodies, and other proteins for additional therapeutic benefit.We are passionate about delivering on the promise of cellular and gene therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients with treatment options.We are seeking individuals who are collaborative, thrive in a fun and dynamic culture, and are steadfast in the commitment to advance cutting-edge cellular therapies to impact patients’ lives.The Director, Pharmacovigilance Scientist, will lead pharmacovigilance activities for assigned development programs, providing both strategic and operational safety leadership. Initially focused on neurology, this role will remain therapeutically flexible to meet organizational needs. The Director will act as the PV lead for assigned programs, partnering with Clinical Development MDs, Safety Physicians, and cross-functional teams to ensure comprehensive oversight of safety strategy, regulatory compliance, risk management, and inspection readiness.Key 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.Minimum 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.BlueRock Therapeutics is ranked in the top 5% of companies for Overall Culture on Comparably.Equal Opportunity Workplace: At BlueRock, we welcome and support differences and diversity and we are proud to be an equal opportunity workplace. Please let us know if you require disability-related accommodation or other grounds protected by human rights legislation during the recruitment process so that we can work with you to meet your needs. #J-18808-Ljbffr