- United Therapeutics (Research Triangle Park, NC)
- …compliance with respect to ISCR processing and reporting. The Lead Pharmacovigilance QC Specialist provides strategic oversight of end-to-end case safety quality, ... biology, or BSN, and 8+ years of experience in pharmacovigilance in either case processing or quality assurance of...chemistry or biology, and 6+ years of experience in pharmacovigilance in either case processing or quality assurance of… more
- Sumitomo Pharma (Raleigh, NC)
- …+ Knowledge of ICH, US & EU regulations, and requirements for Pharmacovigilance . + Excellent interpersonal skills, with demonstrated ability to work in a ... Experience in oncology is highly desired + **Advanced understanding of pharmacovigilance and risk management regulations and guidelines, including pre- and… more
- United Therapeutics (Research Triangle Park, NC)
- …You have a background in nursing or pharmacy and you're passionate about pharmacovigilance . You are a team player who loves quality, compliance, finding solutions ... practices. They will serve as a Subject Matter Expert for pharmacovigilance (PV), quality practices, education/training, and audits/inspections to support both… more
- Sumitomo Pharma (Raleigh, NC)
- …Strategic Alliance (CTSA), PVRM is responsible for the management of the Pharmacovigilance (PVRM) and non-PVRM vendor(s) (eg Commercial) and will be responsible for ... with Quality on corrective action and preventative actions relevant to pharmacovigilance including but not limited to documentation of quality review findings,… more
- United Therapeutics (Research Triangle Park, NC)
- …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 ... This role is responsible for management of Global Product Safety & Pharmacovigilance business alliance activities and contribution to AA&C projects and initiatives.… more
- United Therapeutics (Raleigh, NC)
- …role is critical in ensuring that commercial operational aspects of pharmacovigilance activities are managed with rigorous global standards in proper documentation, ... or related field + 12+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a...bachelor's degree or + 10+ years of experience in pharmacovigilance in end-to-end case processing of ICSRs with a… 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 ... to 1-2 years) in the industry; Or + Direct experience in safety/ Pharmacovigilance (comparable to 2 years) + Experience preference towards individuals with clinical… more
- United Therapeutics (Research Triangle Park, NC)
- …We are seeking an experienced Senior Product Safety Scientist to join our dynamic pharmacovigilance team. You will play a key role in managing the safety profile of ... data from a safety perspective + Intermediate to advanced knowledge of pharmacovigilance processes and regulatory requirements + Advanced knowledge of MedDRA coding… more
- Lilly (Durham, NC)
- …working in at least two of Clinical Operations / Development, Pharmacovigilance , Product Research & Development or Commercial Manufacturing preferred. **A** ... **dditional Information:** + Available to travel (domestic and international) when required. + Fluent in English, additional languages are also recommended. + Role may be based at selected Lilly Locations in Europe or the US. Lilly is dedicated to helping… more
- Grifols Shared Services North America, Inc (Research Triangle Park, NC)
- …and associated reports to internal customers such as R&D, Clinical, Pharmacovigilance , Regulatory and Marketing departments. The Knowledge Services Specialist 2, ... specifically participates in evaluating external information resources for the company's online and electronic collections. Works with scientists and technical colleagues to develop key word searches and assist with in-depth research assignments. Assists with… more