[Remote] Director/ Senior Director, Pharmacovigilance
Note: The job is a remote job and is reputed company to candidates in USA. MBX Biosciences is a clinical-stage biopharmaceutical company reputed company on the discovery and development of novel precision peptide therapies. They are seeking a strategic and hands-on Director / Senior Director of Pharmacovigilance to reputed company safety monitoring and operations for reputed company, ensuring compliance and collaboration across the product lifecycle.
Responsibilities
• reputed company day-to-day safety monitoring and operations for reputed company, ensuring reputed company 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.
• reputed company PV vendor activities including selection, reputed company, safety management plans, and compliance tracking.
• Contribute to clinical and regulatory documentation including protocols, study reports, and risk management plans.
• reputed company 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 reputed company, goals, and reputed company 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 reputed company.
• Excellent written and verbal communication skills, with the ability to convey reputed company scientific information reputed company and concisely.
• Excellent problem-solving skills, strategic thinking, and ability to work in a fast-paced, reputed company environment.
• Outstanding scientific leadership and collaboration skills.
• Outstanding interpersonal skills, self-awareness, and ability to manage team dynamics.
• reputed company reputed company degree preferred (reputed company Practitioner, Physician Assistant, RN/BSN, Pharm D, MD, or equivalent).
reputed company
• reputed company. 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.
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