- Integrated Resources, Inc (Rahway, NJ)
- Job Title: Labeling Specialist Job Location: Rahway, NJ Job Duration: 12 months+ Shift: Hybrid (3 days onsite) Job Description: * Under general supervision, ... of labels and artworks and liaises with departments such as Marketing, Pharmacovigilance and Technical Services to ensure compliance with established regulations. *… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …in therapeutic products and areas; medical coding; safety-data administration + Pharmacovigilance Specialist should possess autonomy and sense of responsibility, ... and regions. **_Job Summary:_** Provides operational support for global pharmacovigilance activities of Grifols marketed products. Ensures pharmacovigilance … more
- Mallinckrodt Pharmaceuticals (Jobe, MO)
- Job Title 安全管理（ファーマコビジランス）業務従事者/Senior Specialist , Pharmacovigilance Requisition JR000012874 安全管理（ファーマコビジランス）業務従事者/Senior Specialist , Pharmacovigilance ... (Open) Location Kobe - JPN304 Additional Locations Kobe Job Description 医療用医薬品の安全管理業務を中心に担っていたいだくポジションです。担当いただく製品は国内外で販売されており、当該医薬品の個別症例情報・文献情報の取扱いとそれらに関連する業務を中心に担っていただきます。業務にあたってはGlobal PVチーム及び国内提携会社との連携も必要となります。… more
- Novo Nordisk (Plainsboro, NJ)
- …+ A minimum of 2 years of progressively responsible, relevant pharmacovigilance experience (including MedDRA coding and adverse event identification) required + ... Customer Service experience preferred + Exceptional knowledge of medical and pharmacovigilance terminology required + Knowledge of NNI supported disease states… more
- Merck (North Wales, PA)
- **Job Description** Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical ... safe, effective, innovative medicine. The Global Clinical Data Standards Vocabulary Specialist , Associate Director, is a subject matter expert in CDISC Controlled… more
- System One (Iron Station, NC)
- Title: Quality Affairs Specialist Location: Iron Station, NC area Schedule: M-F Full Time Type: Direct Hire Responsibilities: The Quality Affairs Specialist ... complaints, adverse events, and communication to Quality Management and Pharmacovigilance . + Perform Complaint Investigations into customer complaints by reviewing… more
- Merck (North Wales, PA)
- …type of agreements related to clinical research. Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and ... and pipeline products to produce safe, effective, innovative medicine. **As a GSA Specialist you will work closely with experienced GSA team to:** + Review Clinical… more
- Actalent (Foster City, CA)
- Quality Assurance Specialist HYBRID role, onsite in Foster City, CA Description: * Receives product complaints for products from the US and Canadian markets. ... for investigation for product complaints and triages safety events to Pharmacovigilance Department. Performs or provides support for product complaint investigations… more
- Actalent (Foster City, CA)
- …for investigation for product complaints and triages safety events to Pharmacovigilance Department. Performs or provides support for product complaint investigations ... * Performs a variety of activities to ensure compliance with applicable regulatory requirements. * Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices… more
- US Tech Solutions (St. Joseph, MO)
- …and apply relevant GMPs and have an understanding of pharmacovigilance and complaint-handling Compliance requirements. **Skills:** + This position requires ... someone with a strong customer service background and a commitment to excellence. + This position must understand the balance of providing customer service in a regulatory compliance environment to ensure strict adherence to all principles of good product… more
- Lilly (Indianapolis, IN)
- …COE, Discovery and Clinical Research, Business Units).Demonstrate knowledge in pharmacovigilance and risk minimization, which includes and understanding of relevant ... Understanding the roles and responsibilities of the European Union Qualified Person for Pharmacovigilance (QPPV). + Ensure support is provided to enable the QPPV to… more
- Adecco US, Inc. (Cambridge, MA)
- …Therapeutic Area department, the individual collaborates with the Coding specialist , Biostatisticians, Data Managers, Global and Regional Study Managers, Feasibility ... Managers, Pharmacovigilance representative, Medical Writer (eg planning and review of...cases with the Clinical Trial Team (Monitoring Teams) or Pharmacovigilance . * Ophthalmology/retina clinical development and clinical operations experience… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …directly to the VP, GMS&G. **Responsibilities:** + Co-manage and support Clinical Safety Specialist (CSS) for their respective BU + Responsibility in the area of ... VP, Global Medical Safety and Governance + Oversight for central MA BD Pharmacovigilance + Participation in oversight activities (eg, Clinical Safety and Drug Safety… more
- Lilly (Indianapolis, IN)
- …level degrees: PhD, PharmD, Nursing with advanced clinical specialty (Clinical Nurse Specialist /Nurse Practitioner). + Combined with a minimum of 1 year experience ... areas relevant to drug discovery or development, eg epidemiology, toxicology, pharmacovigilance , regulatory affairs + Experience within Global Patient Safety or… more
- Boehringer Ingelheim (Ridgefield, CT)
- …candidate will be experienced in clinical research and would be an MD, Retinal Specialist with experience in late stage clinical trials. As an employee of Boehringer ... of cross-functional evidence team (Clinical Operations, Biostatistics, Translational Medicine, Pharmacovigilance , Regulatory, Medical Affairs, Market Access, Epidemiology, RWE etc)… more
- International Rescue Committee (New York, NY)
- …teams during country program led procurements. * Serve as subject matter specialist to HQ and Country Program Supply Chain staff on pharmaceutical regulations, ... prequalification, quality assurance and control, cold chain storage, distribution, and pharmacovigilance . * Good planning and coordination skills and ability to… more
- Bristol Myers Squibb (Seattle, WA)
- …the community, facilitated by their commercial counterpart, TAS (Therapeutic Area Specialist ), to answer unsolicited off-label and technically complex questions in ... agreed upon with home office medical and GDO + Ensure that BMS Pharmacovigilance procedural documents are understood and applied by investigators of local studies,… more
- Bristol Myers Squibb (New York, NY)
- …of gaps in FM resources; collaborates with the Field Medical Communication Specialist (FMCS), TA point, Medical Information and Medical Strategy on development of ... Adverse Events (AEs) and fully understand and comply with BMS Pharmacovigilance SOPs regarding identification and reporting timelines + Contributes to managing… more
- Boehringer Ingelheim (Ridgefield, CT)
- …Medical subteam (Clinical Operations, Biostatistics, Translational Medicine, Pharmacovigilance , Regulatory, Medical Affairs, Market Access, Epidemiology, RWE ... and ethical standards. **Requirements** **Director Program Leader Requirements:** + MD ( specialist in respective TA) from an accredited institution and extensive… more
- AbbVie (Mettawa, IL)
- …Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Provides specialist medical/scientific strategic and operational input into core medical affairs ... in a relevant therapeutic specialty. Must have an understanding of Pharmacovigilance practices for Clinical Development programs. *Ability to interact externally and… more
