- Daiichi Sankyo, Inc. (Bernards, NJ)
- …management experience in PV preferredMinimum of 5 years of Drug Safety / Pharmacovigilance experience, including both investigational and marketed products; ... around rare diseases and immune disorders. Job Summary: Manage Local/Global Pharmacovigilance (PV) service providers responsible for Call Center, individual … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execute audits effectively.Support inspection readiness by preparing clinical teams, Clinical Safety and Pharmacovigilance (CSPV) and post marketing stakeholders ... the Pharmaceutical industry, with involvement in regulated clinical trials, clinical safety , pharmacovigilance included regulatory document reviewMust have at… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in PV; required10 or more years of experience within Drug Safety / Pharmacovigilance experience, including both investigational and marketed products; ... (MedDRA, WHO-DD). preferredExtensive knowledge of FDA regulations, clinical and safety databases, preferredFamiliarity with Good Clinical Procedures (GCP) and Good… more
- Deciphera Pharmaceuticals (Waltham, MA)
- …board eligible or OUS equivalent) Minimum of 5 years of experience in Pharmacovigilance /Drug Safety with development and marketed products in a biopharmaceutical ... 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… more
- Hays Recruitment (Philadelphia, PA)
- …field, or equivalent experience. *Minimum of 8-10 years of experience in pharmacovigilance or drug safety . *In-depth knowledge of regulatory requirements and ... Associate Director, Pharmacovigilance , US - Permanent - Philadelphia, PA -...(NSAEs). *Review and assess adverse event reports and other safety data to identify trends or signals, and escalate… more
- Taiho Oncology (FL)
- …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 territory, eg medical territory plan Training/Education Resource: Develop, maintain and demonstrate scientific expertise… more
- Miltenyi Biotec (Waltham, MA)
- …or other relevant specialty is a plus; Minimum 3 years of Drug Safety / Pharmacovigilance Development (Early and/or Late Phase: develop & deliver program level ... Your Tasks: Reporting to Global Head of Pharmacovigilance , with dotted line reporting to Chief Medical...assigned products, the Associate Medical Director/ Medical Director AMD/MD, Safety Physician will be responsible for evaluating and assessing… 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...Collaborate with medical affairs and clinical teams to address safety signals. Qualifications: PharmD with strong understanding of pharmacology.… more
- Anavex Life Sciences Corp. (New York, NY)
- …support activities related to company sponsored clinical trials to provide required pharmacovigilance contributions such the drafting of Safety Management Plan ... Affairs, and Clinical Research Organization to ensure a timely submission of pharmacovigilance reports (SUSARs, DSURs, REMS, and other safety communications,… more
- Takeda Pharmaceutical Company Limited (Cambridge, MA)
- …activities, assessing issues related to protocol conduct and/or individual subject safety . Assesses 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… 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 ... for key regulatory discussions. Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality… more
- Sanofi Group (Morristown, NJ)
- …clinical development in at least one of the following areas: early development, safety , risk management, pharmacoepidemiology or pharmacovigilance + In depth and ... **Job Title:** PSPV Global Translational Safety Lead **Location** : Cambridge, MA or Morristown,...emerging preclinical data into potential clinical risk + Support Pharmacovigilance teams including Benefit Risk Assessment teams and Translational… more
- Bristol Myers Squibb (San Diego, CA)
- …be the global leader in radiopharmaceuticals . The Executive Director, Head of Pharmacovigilance - Safety Science, is responsible for overseeing all aspects of ... + MD or equivalent (MBBS etc) + 10+ years of experience in pharmacovigilance , safety science, or related area within the pharmaceutical/biotechnology industry, +… more
- Rhythm Pharmaceuticals (Boston, MA)
- …As a PV Specialist, you will have a critical role in shaping the pharmacovigilance function/department and evaluating the safety of patients who receive our ... and safety activities to ensure and promote compliance with pharmacovigilance standards and operational consistency across programs. + Assists in reconciliation… more
- Sanofi Group (Morristown, NJ)
- …Participation in the ongoing permanent inspection preparedness and readiness of Patient Safety and Pharmacovigilance (PSPV) and country PV offices in ... **Job Title:** Pharmacovigilance Audit and Inspection Readiness Expert **Location:** Morristown,...GPV functions. + PV Quality Liaison role for Country Safety Heads / Multi-Country Safety Heads for… more
- Grifols Shared Services North America, Inc (Los Angeles, CA)
- …guidelines + Expertise in therapeutic products and areas; medical coding; safety -data administration + Pharmacovigilance Specialist should possess autonomy and ... and regions. **_Job Summary:_** Provides operational support for global pharmacovigilance activities of Grifols marketed products. Ensures pharmacovigilance … more
- Takeda Pharmaceuticals (Boston, MA)
- …by the position's seniority/experience. You will also be involved in signal detection/ safety monitoring activities for pharmacovigilance operations with a lead ... ensure the most efficient and timelyattainment of compliant and patient-focused safety data. + Represent the pharmacovigilance department in cross-functional… more
- Sumitomo Pharma (Lincoln, NE)
- …in cross-functional Steering Committee meetings and at partner meetings including Joint Safety Forums (JSFs) and Pharmacovigilance Committee (PVC) meetings. + ... **Education and Experience** + Minimum 4-7+ years of relevant pharmacovigilance or drug safety experience in the...4-7+ years of relevant pharmacovigilance or drug safety experience in the biotechnology or pharmaceutical industry; prior… more
- BeOne Medicines (San Mateo, CA)
- …field or biological science and 4+ years of experience as a Safety ( Pharmacovigilance ) Scientist.ORMD (or internationally recognized equivalent) plus accredited ... **General Description:** _The Associate Director, Safety Scientist supports assigned compounds in conjunction with Product Safety Leads (PSLs) and leverages… more
- United Therapeutics (Research Triangle Park, NC)
- …across functions. This role is responsible for management of Global Product Safety & Pharmacovigilance business alliance activities and contribution to AA&C ... an option. **Who You Are** Do you have a deep understanding of pharmacovigilance (PV) regulations globally and their operational implications for a wide range of… more
