- Ascendis Pharma (Palo Alto, CA)
- …B. Pharm, PharmD, RN etc.) + Candidates with advanced scientific degrees and extensive drug safety experience is highly desired. + Minimum of 10 years recent ... 5 years of people management experience (preferred). + Working knowledge of validated Drug Safety Databases (Argus preferred) + Experience with MedDRA coding and… more
- Astellas Pharma (Northbrook, IL)
- …RWE, modelling, simulation, machine learning teams from clinical trials and drug development process, and life cycle management, including medical affairs statistics ... packages. The VP will partner with key stakeholders in development, pharmacovigilance , clinical operations, medical affairs, and commercial strategy to drive an… more
- Takeda Pharmaceuticals (Boston, MA)
- …and AI/Machine Learning to support the department's data needs; Solve business problems in drug safety which provide an increased understanding of such tools and ... (PV) reporting & analytic solutions for Takeda Patient Safety & Pharmacovigilance (PSPV); Identify and develop...related experience. Prior experience must include: Utilize knowledge of drug safety systems, including the underlying data… more
- Takeda Pharmaceuticals (Boston, MA)
- …of experience in people management. + Demonstrated knowledge of regulatory agency requirements regarding drug safety and an understanding of general drug ... company-wide Committees and Governance. As part of the Patient Safety and Pharmacovigilance (PSPV) team, you will...analyses of safety information, in support of safety update regulatory submissions, investigational and new drug… more
- Lundbeck (Deerfield, IL)
- …EDUCATION, EXPERIENCE, and SKILLS:** + Accredited MD/DO (MBBS, MBCHb, MBBCh) + 5+ years drug safety experience in a biotech or pharmaceutical company + Ability ... to drive drug safety evidence generation and risk mitigation...Excellent working knowledge of local and global regulations/guidelines in pharmacovigilance and risk management, REMS programs. + Detailed understanding… more
- BeOne Medicines (San Mateo, CA)
- … sections of global regulatory inquiries and periodic reports including Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Report ... **_General Description:_** The Senior Manager, Safety Scientist supports assigned compounds in conjunction with...integrated Benefit/Risk assessments Promote and Advance the Field of Pharmacovigilance . Any other tasks assigned by manager to… more
- AbbVie (North Chicago, IL)
- …toxicology to effectively conduct safety surveillance 2. Responsible for safety surveillance for pharmaceutical / biological / drug -device combined ... pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses, aggregate reports. 4. Apply current regulatory… more
- United Therapeutics (Phoenix, AZ)
- …plays a key role in management and oversight of end-to-end case safety management activities spanning across our global commercial product portfolio. This position ... to ensure compliance with global regulations and guidelines with regards to safety data collection, management and reporting for postmarketing ICSRs for efficiency,… more
- Takeda Pharmaceuticals (Boston, MA)
- …Affairs, Regulatory Affairs, Biostats) to ensure alignment of global position for pharmacovigilance risk management processes to maximize patient safety + ... strategic expertise to cross-functional product team members in developing pharmacovigilance risk strategies including benchmarking and scenario planning. + Support… more
- Rhythm Pharmaceuticals (Boston, MA)
- …with an advanced understanding of requirements for clinical trials and drug development, regulatory submissions, pharmacovigilance reporting and medical ... as oversee the development and advancement of clinical, regulatory, medical and safety documents spanning across the development lifecycle. This role reports to the… more