- Deciphera Pharmaceuticals (Waltham, MA)
- …seeking a Medical Director . This position will report to the Senior Medical Director of Pharmacovigilance and will be located in the Waltham office. The ... Medical Director is responsible for global pharmacovigilance (PV) for marketed and/or investigational products, including review and analysis of safety data from… more
- Nuvalent, Inc. (Cambridge, MA)
- …drug development, and company building. The Role: Reporting to the Senior Medical Director , Pharmacovigilance , the Associate Director , Drug Safety and ... the role, strong and current knowledge of drug safety and pharmacovigilance regulations, pharmacovigilance practices, safety surveillance and risk-management… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …oversight groups for case processing activities and reports to the Director of PV Case Management.Responsibilities:ICSR Processing: Oversees QC activities, supports ... PV; required10 or more years of experience within Drug Safety/ Pharmacovigilance experience, including both investigational and marketed products; preferredExtensive… more
- Formation Bio (New York, NY)
- …treatments to patients faster and more efficiently. About the Position The Director of Medical Writing will be responsible for developing and implementing medical ... regulatory documents (meeting and briefing packages, regulatory filings); and pharmacovigilance documents (eg, annual reports/developmental safety update reports) by… more
- Edgewise Therapeutics (Boulder, CO)
- Senior Director /Executive Director , Clinical Quality Assurance About Edgewise Therapeutics: At Edgewise, we are on a mission to discover new medicines that ... Therapeutics is seeking an accomplished and strategic leader to serve as Senior Director or Executive Director , Clinical Quality Assurance (CQA) (level to be… more
- BioSpace (Boston, MA)
- …the best of my knowledge. Job Description About the role: The Associate Director , Clinical and Safety Quality Compliance is responsible for ensuring the quality of ... compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and procedures and determined by… more
- BioSpace (Bridgewater, NJ)
- …(TM) , and Best Medium Workplaces (TM) lists. Overview The Executive Director (ED) will lead Global Medical Safety Strategy for all Insmed's investigational ... implementing corrective and preventative actions. Oversee medical safety and pharmacovigilance activities conducted with external partners including contract research… more
- Kailera Therapeutics, Inc. (Waltham, MA)
- …perspectives, and experiences to join our team. What You'll Do: The Associate Director , Clinical Data Management plays a key role within the Clinical Development ... data management representative on the study management team, the Associate Director coordinates ongoing DM activities, partnering closely with key stakeholders to… more
- Nature Careers (Cambridge, MA)
- About This Role The primary purpose of the Associate Director , Epidemiology position is to provide epidemiologic expertise (conceptual, methodological and ... including Safety, Clinical Development, Medical, and Value & Access. The Associate Director , Epidemiology, under the guidance of the Director , Epidemiology, and… more
- Kailera Therapeutics, Inc. (Waltham, MA)
- …and experiences to join our team. What You'll Do: As the Associate Director of Biostatistics, you will lead the statistical support for clinical studies, ensuring ... by collaborating with cross-functional teams. Partner with medical, regulatory, pharmacovigilance , pharmacology, clinical operations, and other functions to ensure… more
- ProPharma Group (Western Springs, IL)
- …in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance , medical information, and R&D technology, ProPharma offers an end-to-end ... accelerate our partners' most high-profile drug and device programs. The Associate Director , Principal Medical Writer II is responsible for the development of… more
- Bristol-Myers Squibb Company (New Brunswick, NJ)
- …data generation, insight generation and patients' access to medicine. The Regional Associate Director (RAD) role is field-based and focused on managing a team of ... Adverse Events (AEs) and fully understand and comply with BMS Pharmacovigilance SOPs regarding identification and reporting timelines Contributes to managing… more
- Cardinal Health (Indianapolis, IN)
- …defined expense budget, unless otherwise directed. Communicate frequently with Director regarding progress, accomplishments, needs, and key observations related to ... partners and internal stakeholders. Be very familiar with and observe all pharmacovigilance policies and procedures and ensure that any product adverse events are… more
- Bristol Myers Squibb (San Diego, CA)
- …RayzeBio aims to be the global leader in radiopharmaceuticals . The Executive Director , Head of Pharmacovigilance - Safety Science, is responsible for overseeing ... and post-marketing surveillance. This key leadership role ensures that pharmacovigilance (PV) activities align with regulatory requirements and company standards,… more
- Sumitomo Pharma (Pierre, SD)
- …highly motivated, and experienced individual for the position of **Associate Medical Director .** The Associate Medical Director will provide hands-on PVRM ... + Knowledge of ICH, US & EU regulations, and requirements for Pharmacovigilance . + Excellent interpersonal skills, with demonstrated ability to work in a… more
- Rhythm Pharmaceuticals (Boston, MA)
- …the activities of Rhythm's safety vendor. This position will report to the Director of Pharmacovigilance . Responsibilities and Duties + Reviews adverse event ... you will have a critical role in shaping the pharmacovigilance function/department and evaluating the safety of patients who...teams, as needed. + May serve as delegate for Director as indicated. + Performs other PV activities as… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** **About the role:** Join Takeda as a Senior Medical Director , Pharmacovigilance in Gastrointestinal and Inflammation (GI2). You will oversee ... and Governance. As part of the Patient Safety and Pharmacovigilance (PSPV) team, you will report to the Vice...Takeda Safety Board and similar forums. The Senior Medical Director will be a key player in the preparation… more
- J&J Family of Companies (Raritan, NJ)
- …as KOL in the field. + Safeguard patient safety. Support Sr. Medical Director in Pharmacovigilance activities, reviewing periodic safety reports and adverse ... **Job Description:** Johnson and Johnson is currently seeking a **Medical Director , Global Medical Affairs, Biosurgery located** in **Raritan, NJ** **About Surgery**… more
- Takeda Pharmaceuticals (Boston, MA)
- …therapies to patients worldwide. Join Takeda as a **Senior** **Principal Pharmacovigilance Scientist** where you will provide pharmacovigilance functional area ... developmental and marketed products and be responsible for operational pharmacovigilance activities for assigned developmental and marketed products. You will… more
- Lilly (Indianapolis, IN)
- …better for people around the world. **Purpose:** The purpose of the Senior Director - Benefit-Risk Management Group Leader is to lead the development and ... and understanding of regulations, guidelines, and regulatory precedence. The Senior Director will ensure that the Benefit-Risk Management group maintains compliance… more
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