- ThermoFisher Scientific (Greenville, NC)
- …(comparable to 1-2 years) in the industry; Or + Direct experience in safety/ Pharmacovigilance (comparable to 2 years) **For Medical Director Level:** + MD ... background check, which includes a drug screening. Our detailed, goal-oriented Pharmacovigilance colleagues manage the safety profile of new drugs in clinical… more
- ThermoFisher Scientific (Wilmington, NC)
- …instructions, forms, templates) + Support adverse event reporting training and pharmacovigilance awareness activities cross functionally + Support the preparation of ... pharmacovigilance agreements with clinical development or commercial business partners...the pharmaceutical/biotech industry with at least 5 years in pharmacovigilance /drug safety (global experience is a plus) + At… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …training programs in GxP compliance, Ethics & Compliance, and Pharmacovigilance , ensuring alignment with regulatory requirements and business objectives. This ... (Good Manufacturing/Clinical/Laboratory Practice) compliance + Ethics and Compliance + Pharmacovigilance + Partner with Quality, Regulatory, R&D, Manufacturing, Supply… more
- Parexel (Raleigh, NC)
- …local sponsorship as needed with the support of the designated Senior Medical Director / Global Head of TA (as appropriate) Pharmacovigilance Support * Provide ... our esteemed Medical Sciences Team and seeking an Associate/Medical Director to support the growth of our Global Immunology...and Inflammation Therapeutic Franchise. As an Associate / Medical Director , you will work closely with some of the… more
- CREO (NC)
- JOB DESCRIPTION OVERVIEW The Director , Business Development specializing in Quality & Regulatory Compliance will be responsible for conducting market research to ... as well as close sales and finalize agreements with customers. The Director , Business Development will work closely with various CREO industry and line… more
- Lilly (Durham, NC)
- …to make life better for people around the world. **Responsibilities** The Senior Director , Global Process Owner for Quality Risk Management, as a leader within the ... industry trends and scientific principles. **Key Objectives/Deliverables** The Senior Director , Global Process Owner for Quality Risk Management is responsible… more
- Sumitomo Pharma (Raleigh, NC)
- …motivated, and experienced individual for the position of **Associate** **Medical Director , Clinical Development - Oncology** . The associate medical director ... for INDs, NDAs, and other related documents. + Partner with Drug Safety & Pharmacovigilance to assess the safety profile of compounds. + Maintain a high level of… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- The Associate Director of Regulatory Intelligence leads the collection and dissemination of regulatory intelligence and collaborates with SMEs to interpret the ... EMA, PMDA, ICH, etc. + General knowledge of global regulations for pharmacovigilance reporting for approved and investigational products. + Confirm list of upcoming… more
- Pfizer (Raleigh, NC)
- …alternate site clinic negotiations, and formulary inclusion for biosimilars. + Pharmacovigilance and post-market safety monitoring. + Preferred: + Oncology and/or ... Immunology & Inflammation therapeutic area expertise. + Proven success engaging Academic Medical Centers, Integrated Delivery Networks (IDNs), and large group practice community accounts. + Strong understanding of evolving healthcare landscape in US, including… more
- Cardinal Health (Charlotte, NC)
- …defined expense budget, unless otherwise directed. + Communicate frequently with Director regarding progress, accomplishments, needs, and key observations related to ... partners and internal stakeholders. + Be very familiar with and observe all pharmacovigilance policies and procedures and ensure that any product adverse events are… more