- Lupin Pharmaceuticals (Coral Springs, FL)
- …safety signals, adverse events, and efficacy data in collaboration with pharmacovigilance teams. Target Product Profile (TPP) Contributions: Develop and refine TPPs ... by outlining desired product characteristics such as indications, target population, dosing regimen, safety profile, and clinical efficacy.Align TPPs with regulatory requirements and commercial goals to guide product development strategies. Due Diligence… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily ... preferred Experience:4 or More Years 5-7 years of relevant experience in pharmacovigilance within the pharmaceutical industry required4 or More Years At least 4… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …PV; required10 or more years of experience within Drug Safety/ Pharmacovigilance experience, including both investigational and marketed products; preferredExtensive ... safety databases, preferredFamiliarity with Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP) preferred Daiichi Sankyo, Inc. is an equal… more
- Monster (Plainsboro, NJ)
- Title: Global Drug Safety and PV Compliance Associate Location: Must be local for hybrid schedule in Princeton area Rate: Up to $42/hour (dependent on experience) ... is onsite at any time. Flexibility. Pharma company seeking an experienced, detail-driven Associate to support the Compliance Team within the Global Drug Safety and … more
- Monster (Bernards, NJ)
- …a global role that will cover signal activity across all DS regions. The Associate Director of the Signal Management Center of Excellence (CoE) will lead the daily ... preferred Experience: 4 or More Years 5-7 years of relevant experience in pharmacovigilance within the pharmaceutical industry required 4 or More Years At least 4… more
- Sumitomo Pharma (Augusta, ME)
- …a dynamic, highly motivated, and experienced individual for the position of ** Associate Medical Director.** The Associate Medical Director will provide hands-on ... + Knowledge of ICH, US & EU regulations, and requirements for Pharmacovigilance . + Excellent interpersonal skills, with demonstrated ability to work in a… more
- Gilead Sciences, Inc. (Foster City, CA)
- …aspirations. Join Gilead and help create possible, together. **Job Description** The Associate Director, Good Pharmacovigilance Practice (GVP) Audits, serves as ... lead complex audits across the broader R&D, vendor, and pharmacovigilance workstreams. This position requires close collaboration with cross-functional stakeholders,… more
- Takeda Pharmaceuticals (Boston, MA)
- …**OBJECTIVES:** + Provides oversight from a clinical research and pharmacovigilance perspective of regulated post-authorization activities in the commercial business ... affiliate and enables them to deliver their clinical research and pharmacovigilance -related regulated activities with high compliance and agility. + Establish and… more
- Actalent (Frederick, MD)
- …a highly motivated professional who can oversee Quality Assurance clinical operations. The Associate Director of QA will oversee quality for GCP, GLP, and PV ... Operations and CRO teams. * Supports the implementation and management of the Pharmacovigilance (PV) Quality Management System (QMS) and PV System for clinical and… more
- Ascendis Pharma (Palo Alto, CA)
- …offer a dynamic workplace for employees to grow and develop their skills. The Associate Director, PV Vendor Management Team reports to the Director, Head, PV Vendor ... the assigned Vendor Management activities in Ascendis. Key Responsibilities Pharmacovigilance related responsibilities over GVP, Patient Support Programs (PSPs) and… more
- Takeda Pharmaceuticals (Boston, MA)
- …and empower you to shine? Join us as a PV Risk Management Scientist/ Associate Director. At Takeda, we are transforming the pharmaceutical industry through our ... encourage innovation, and strive for excellence in everything we do. As an Associate Director/ PV Risk Management Scientist, being part of our Risk Management and… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **About the role:** The Associate Director, Clinical and Safety Quality Compliance is responsible for ensuring the ... compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and procedures and determined by… more
- ThermoFisher Scientific (Wilmington, NC)
- …find cures for cancer. **Location/Division Specific Information** Our detailed, goal-oriented Pharmacovigilance colleagues manage the safety profile of new drugs in ... and oversight of all contracted services. **Discover Impactful Work:** The Associate /Medical Director provides medical oversight of clinical trials to ensure company… more
- IQVIA (Durham, NC)
- **J** **ob Overview** The Associate Medical Director / Medical Director will provide medical, clinical and scientific advisory expertise to all IQVIA divisions as ... review of case documentation and patient narrative, in collaboration with the Pharmacovigilance department. + May provide medical support for the Analysis of Similar… more
- Takeda Pharmaceuticals (Boston, MA)
- …to the best of my knowledge. **Job Description** **About the role:** Associate Director, Clinical Program Quality Investigations is responsible for ensuring the ... Clinical Program Quality team and share insights to trends to Clinical Pharmacovigilance and Medical Quality and R&D Quality leadership for proactive risk mitigation… more
- Takeda Pharmaceuticals (Boston, MA)
- …CPMQ activities eg audit, inspection, QE, CAPA. + Organise Clinical and Pharmacovigilance Quality council meetings and proactively manage the agenda and ensure key ... include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections, investigations and remediation… more
- AbbVie (Irvine, CA)
- …. Job Description Purpose: Group Medical Director manages other Associate Medical Directors, Medical Directors, Senior Medical Directors. Leading Product ... signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Experts on hematology-oncology… more
- System One (Plainsboro, NJ)
- Title: Global Drug Safety and PV Compliance Associate Location: Must be local for hybrid schedule in Princeton area Rate: Up to $42/hour (dependent on experience) ... is onsite at any time. Flexibility. Pharma company seeking an experienced, detail-driven Associate to support the Compliance Team within the Global Drug Safety and … more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. The purpose of the Associate Director - Safety Data Scientist is to manage and analyze complex Global Patient ... assess business issues, and drive analytic solutions. The Safety Data Scientist Associate Director / Director will work with stakeholders to analyze workflows and… more
- PSKW LLC dba ConnectiveRx LLC (Pittsburgh, PA)
- …improve processes, procedures, and training. Ensures the team follows all pharmacovigilance processes, including timely submission of AE/PQC and completion of ... as needed. Qualifications Knowledge, Skills, and Experience Education/Degree Requirements/Certifications: Associate 's degree or equivalent experience (4 years) required in… more
