- Daiichi Sankyo, Inc. (Bernards, NJ)
- …around rare diseases and immune disorders. Job Summary: Manage Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual safety ... and AE reporting language in associated contractual templates. Ensures Good Pharmacovigilance Practice and regulatory compliance in such arrangements. Contribute to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …inspection readiness by preparing clinical teams, Clinical Safety and Pharmacovigilance (CSPV) and post marketing stakeholders for key Health Authority ... Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety, pharmacovigilance included regulatory document reviewMust have at least 4 or… 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
- Merck & Co. (Rahway, NJ)
- …Employee Training Programs, FDA Regulations, Management Process, Pharmacovigilance , Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, ... Regulatory Labeling, Regulatory Operations, Regulatory Submissions, Strategic Thinking, Systems Development Lifecycle (SDLC), Vendor Management-Preferred Skills:Job Posting End Date:08/2/2025 *A job posting is effective until 11:59:59PM on the day BEFORE -the… more
- Taiho Oncology (FL)
- …Respond to unsolicited medical information requests in the field. Fulfill Pharmacovigilance responsibilities as defined in the pharmacovigilance SOPs related ... to medical inquiries and drug safety information. Use medical affairs plans to develop and align the tactical plan for Sr. Manager, Medical Field geography of responsibility and implement plans to support Medical Affairs strategic direction for assigned… more
- Deciphera Pharmaceuticals (Waltham, MA)
- …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 post-marketing sources… more
- Atrium: Staffing (Cambridge, MA)
- …Our client is a mid-sized pharmaceutical company and is looking for a Pharmacovigilance QA Manager ! Salary/Hourly Rate: $100/hr - $110/hr Position Overview: The ... Pharmacovigilance QA Manager will oversee post marketing PV systems....program and contribute to inspection readiness. Responsibilities of the Pharmacovigilance QA Manager: Ensure compliance with Global PV regulation.… more
- Hays Recruitment (Philadelphia, PA)
- Associate Director, Pharmacovigilance , US - Permanent - Philadelphia, PA - $140000.00 - $140000.00/hr. The final salary or hourly wage, as applicable, paid to each ... Sponsorship not available. Our client is seeking an Associate Director, Pharmacovigilance , US in Philadelphia, PA. Role Description Pharmacovigilance Oversight:… more
- Pharmacy Careers (Corona, CA)
- Pharmacovigilance Pharmacist Bring your clinical lens to the world of drug safety and reporting. Key Responsibilities: Analyze adverse event reports and clinical ... trial safety data. Prepare regulatory submissions (eg, MedWatch, PSURs). Collaborate with medical affairs and clinical teams to address safety signals. Qualifications: PharmD with strong understanding of pharmacology. Prior experience in drug safety or… more
- Anavex Life Sciences Corp. (New York, NY)
- …for our partners across major therapeutic areas. Senior/Executive Director, Global Pharmacovigilance Apply Summary of Position Anavex Life Sciences Corp. is seeking ... a talented and highly motivated pharmacovigilance director/Sr. director to join our team. This position...according to time, quality, scope, and budget parameters. The Pharmacovigilance director is the primary point of contact for… more
- ADC Therapeutics SA (New Providence, NJ)
- …Science, Clinical Operations, Development, GMP Quality Assurance, Biostatistics, Pharmacovigilance , Clinical Supply Chain, Regulatory Affairs, Legal, and Executive ... on GCP quality-related matters. *PV Quality: Establish and manage Pharmacovigilance Quality Assurance processes *Other duties as assigned Requirements Who… more
- Miltenyi Biotec (Waltham, MA)
- Your Tasks: Reporting to Global Head of Pharmacovigilance , with dotted line reporting to Chief Medical Officers (CMO) for assigned products, the Associate Medical ... or other relevant specialty is a plus; Minimum 3 years of Drug Safety/ Pharmacovigilance Development (Early and/or Late Phase: develop & deliver program level safety… more
- Takeda Pharmaceutical Company Limited (Cambridge, MA)
- …overall safety information for studies and compound in conjunction with Pharmacovigilance . Oversees non-medical clinical scientists with respect to assessment of ... these issues. *Makes final decisions regarding study conduct related to scientific integrity. o External Interactions *Directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to… more
- Lifelancer (Cincinnati, OH)
- …with all laws, regulations, and policies including adverse events / pharmacovigilance responsibilities. Perform additional duties as may be assigned. Education And ... Experience Bachelor's degree required, scientific degree or coursework a plus 5 to 9 years of proven track record of sales success within Rare Diseases, Hematology and Oncology Proven track record of consistently exceeding sales targets Experience with… more
- Lifelancer (Hartford, CT)
- …with all laws, regulations, and policies including adverse events / pharmacovigilance responsibilities. Perform additional duties as may be assigned. Education And ... Experience Bachelor's degree required, scientific degree or coursework a plus Proven track record of sales success within rare diseases, endocrinology and/or biotechnology industries Proven track record of consistently exceeding sales targets Experience with… more
- AbbVie (North Chicago, IL)
- …for key regulatory discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality ... standards in conducting research. Qualifications Medical Doctor (MD), Doctor of Osteopathy (DO) or non-US equivalent of MD degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred.… 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
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …and regions. **_Job Summary:_** Provides operational support for global pharmacovigilance activities of Grifols marketed products. Ensures pharmacovigilance ... Grifols pharmaceutical products. + Contributes to ensure compliance of pharmacovigilance activities including activities such as conduct case reconciliation with… more
- Bristol Myers Squibb (San Diego, CA)
- …the global leader in radiopharmaceuticals . The Executive Director, Head of Pharmacovigilance - Safety Science, is responsible for overseeing all aspects of product ... and post-marketing surveillance. This key leadership role ensures that pharmacovigilance (PV) activities align with regulatory requirements and company standards,… more
- Amgen (Washington, DC)
- …us and transform the lives of patients while transforming your career. **Global Pharmacovigilance (PV) Senior Scientist** **What you will do** Let's do this. Let's ... these qualifications. **Basic Qualifications:** Doctorate degree and 2 years of pharmacovigilance experience Or Master's degree and 6 years of pharmacovigilance… more
