- Daiichi Sankyo, Inc. (Bernards, NJ)
- …is 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 ... and innovate signal detection and management processes across the global safety organization. The incumbent will ensure regulatory compliance, promote best… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …Medical Monitoring: Provide medical oversight during clinical trials to ensure participant safety and data integrity.Review and interpret safety signals, adverse ... events, and efficacy data in collaboration with pharmacovigilance teams. Target Product Profile (TPP) Contributions: Develop and refine TPPs by outlining desired… more
- AbbVie (Chicago, IL)
- …CAPA investigations as necessary Qualifications + MD or equivalent + Associate Medical Director I - Drug safety experience preferred but not required + ... + Performs causality assessment of adverse events in post-marketing individual case safety reports. + Understands safety profile of assigned AbbVie products… more
- AbbVie (North Chicago, IL)
- …the direction of the Group Medical Director and Executive Medical Director in ensuring safety through surveillance, signal detection, validation, and ... assessment. Interpreting regulations related to pharmacovigilance , supporting all patient safety activities. Responsibilities: * Understands and applies… more
- Ascendis Pharma (Princeton, NJ)
- …We offer a dynamic workplace for employees to grow and develop their skills. The Associate Director , ICSR Management Team reports to the Director , Head, ICSR ... Safety Database. + Reviews and provides input to Business Partner or Pharmacovigilance Agreements and Safety Data Exchange Agreements (SDEA) to ensure… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. Purpose: The purpose of the Associate Director , Safety Management is to provide technical leadership to all ... for projects, improvements, and standardization across the group. The Associate Director is the subject matter expert...BSN, MSN preferred). + 3+ years of experience within safety management. + Proven expertise in Pharmacovigilance … more
- ThermoFisher Scientific (Wilmington, NC)
- …(comparable to 1-2 years) in the industry; Or + Direct experience in safety / Pharmacovigilance (comparable to 2 years) **For Medical Director Level:** + MD or ... comprehensive background check, which includes a drug screening. Our detailed, goal-oriented Pharmacovigilance colleagues manage the safety profile of new drugs… more
- AbbVie (North Chicago, IL)
- …and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose: Group Medical Director manages other Associate Medical Directors, Medical Directors, ... signal detection, validation and assessment). Interpreting regulations related to pharmacovigilance supporting all patient safety activities. Experts on… more
- Takeda Pharmaceuticals (Boston, MA)
- …true to the best of my knowledge. **Job Description** **About the role:** The Associate Director , Clinical and Safety Quality Compliance is responsible for ... in partnership with functional compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and… more
- IQVIA (Durham, NC)
- **Job Overview** The Associate Medical Director will provide medical, clinical and scientific advisory expertise to all IQVIA divisions as requested. Participate ... including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility. + Performs medical review of the protocol,… more
- Parexel (Helena, MT)
- …broad spectrum of diseases. Overall responsibilities of the Associate / Medical Director are to: * Provide medical and safety monitoring for assigned ... anticipation of future needs, we are seeking an additional Associate / Medical Director to join Parexel's...needed with the support of the designated Senior Medical Director / Global Head of TA (as appropriate) Pharmacovigilance… more
- Takeda Pharmaceuticals (Boston, MA)
- …Lead CPMQ continuous improvement initiatives to enable optimization of clinical and safety quality compliance activities. + Provide expert advice and support to the ... CPMQ activities eg audit, inspection, QE, CAPA. + Organise Clinical and Pharmacovigilance Quality council meetings and proactively manage the agenda and ensure key… more
- Kelly Services (Cambridge, MA)
- **Contract Clinical Trial Physician - Pediatrician** Remote East Coast + Contract Associate Medical Director (Clinical Trial Physician) + East coast based - ... (comparable to 1-2 years) in the industry + Or direct experience in safety / Pharmacovigilance (comparable to 2 years) + In some cases, an equivalency, consisting… more
- AbbVie (Cambridge, MA)
- …integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is ... responses and discussions. + Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality… more
- AbbVie (North Chicago, IL)
- …integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is ... and responses, and other program documents. + May oversee the work of Associate Medical and/or Scientific Directors, and of Clinical Scientists working on the same… more
- Boehringer Ingelheim (Duluth, GA)
- …programs reflect Boehringer Ingelheim's high regard for our employees. The Senior Associate Director , GPV Surveillance & Epidemiology leads the strategic design, ... Product Surveillance & Risk Management (PSRM) program within Global Pharmacovigilance (GPV). The incumbent translates evolving and complex regulatory authority… more
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