[Remote] Director/ Senior Director, Pharmacovigilance

Note: The job is a remote job and is open to candidates in USA. MBX Biosciences is a clinical-stage biopharmaceutical company focused on the discovery and development of novel precision peptide therapies. They are seeking a strategic and hands-on Director / Senior Director of Pharmacovigilance to lead safety monitoring and operations for clinical trials, ensuring compliance and collaboration across the product lifecycle. Responsibilities • Lead day-to-day safety monitoring and operations for clinical trials, ensuring timely and compliant safety reporting • Serve as PV subject matter expert across clinical development teams and internal governance forums. • Support signal detection, validation, and risk mitigation strategies. • Oversee PV vendor activities including selection, contracts, safety management plans, and compliance tracking. • Contribute to clinical and regulatory documentation including protocols, study reports, and risk management plans. • Lead development and submission of DSURs, PSURs, PADERs, and other aggregate safety reports. • Ensure audit and inspection preparedness, including TMF support and PV system organization. • Create and maintain SOPs, safety management plans, and training materials for PV operations. • Manage PV agreements and operational support for licensing partners and collaborations. • Contribute to PV organizational strategy, goals, and continuous improvement initiatives. • Other responsibilities as assigned. Skills • Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent degree with pharmaceutical industry background and proven competence in PV. • 12+ years’ pharmaceutical industry experience, including a minimum of 5 years’ experience in PV. • Demonstrated experience in analysis and interpretation of medical and scientific data, including experience in both post-marketing and clinical trials. • Excellent written and verbal communication skills, with the ability to convey complex scientific information clearly and concisely. • Excellent problem-solving skills, strategic thinking, and ability to work in a fast-paced, collaborative environment. • Outstanding scientific leadership and collaboration skills. • Outstanding interpersonal skills, self-awareness, and ability to manage team dynamics. • Healthcare professional degree preferred (Nurse Practitioner, Physician Assistant, RN/BSN, Pharm D, MD, or equivalent). Company Overview • MBX Biosciences, Inc. is a clinical stage biopharmaceutical company pioneering investigational Precision Endocrine Peptides (PEPs™). It was founded in 2019, and is headquartered in Carmel, Indiana, USA, with a workforce of 11-50 employees. Its website is https://www.mbxbio.com.