Requests
0
Keep in touch with meI'm using Intch to connect with new people. Use this link to open chat with me via Intch app
Work Background
Perspective Pharmacovigilance, Inc.Sr. Strategic PV Advisor
Sep. 2022United StatesManage a small group of PV consultants for various global client projects. Focus on strategy and successful delivery and tracking of major PV deliverables, PV Ops and Compliance work, helping prepare companies for NDA/BLA and MAA PV obligations and general PV inspection readiness. Also support RFP/selection of safety CROs and/or consideration of different global safety database models.
Perspective Pharmacovigilance, Inc.Sr. PV Consultant
Feb. 2021 - Sep. 2022San Francisco Bay AreaSenior PV consultant with 20 yrs of experience in various safety operations and PV-compliance leadership roles with in-depth experience with global PV departments in the set up and management of PV inspection readiness, SOP, training and compliance performance indicators/metrics, REMS program management oversight, EU PSMF set-up and management, and global safety CRO management & oversight in both clinical and post-marketed safety phases of a company’s maturity
BeiGeneSr. Director, Safety Operations
Apr. 2017 - Feb. 2021Emeryville, California
Gilead SciencesDirector, Drug Safety & Public Health Operations
Jan. 2013 - Apr. 2017Foster City*Operational oversight of multiple REMS programs, Project Management Support of global epidemiology studies (eg; PASS) and oversight of Drug Safety Operations global submissions (ICSRs, monthly line listings, aggregate reports and partner submissions)
*Works cross-functionally and with REMS program vendor(s) to ensure deliverables are completed on time, within budget, and in accordance with REMS program requirements *Ensures that REMS project specific staff training and REMS program materials (eg; SOPs, approvals, supporting documents, REMS websites, educational forms/guides) are maintained and upversioned as appropriate with each REMS modification
*Project management support to Epidemiology team in the timely set up, maintenance and execution of REMS Assessment deliverables, and study deliverables for all global post-authorisation safety studies (PASS)
*Supports updates to REMS vendor and/or Specialty Pharmacy contracts with respect to Drug Safety requirements
BioMarinDirector, Pharmacovigilance
Mar. 2010 - Jan. 2013• Supervision of, collaboration with, and delegation to other members of the team to facilitate day-to-day drug safety activities
• Ensure compliance with all global regulatory reporting requirements and timelines for safety data, and proactively address safety issues for all commercial and pre-marketed • Participate in product-specific teams
• Interface with corporate partners in the exchange and presentation of safety information, negotiation of safety data exchange agreements
• Review high-level deliverables and budgets across department with respect to staff, vendors, consultants and business partners
Amylin PharmaceuticalsAssociate Director, Global Safety Operations
Jan. 2004 - Mar. 20101. Responsible for oversight of GCP compliance initiatives, training programs, records management, metrics development and lead audit/inspection readiness coordination 2. Line management of 5 staff members 3. Department lead for GCP & GMP Quality lead team initiatives that are relevant to Global Safety Operations
Amylin PharmaceuticalsSr. Manager, Global Safety Operations
Jan. 2004 - Aug. 20051. Responsible for management oversight of Clinical Safety Operations for Global Safety Department 2. Lead for department budget(s) 3. Line management of 5-8 staff members
Elan PharmaceuticalsSr. Global Safey Scientist, Neurology Team Leader
Nov. 2001 - Jan. 20041. Responsible for case management and expedited report submission of all neurology therapeutic products 2. Co-lead for new employee training & mentorship 3. Supervisory responsibility of 3-4 staff members 4. Assisted medical team with epidemiological analyses
CEIPSurveillance Officer
Jan. 1999 - Jan. 2001
Intch is a Professional Networking App for the Future of WorkSee more people like Ariela on Intch
300k+ people
130+ countries
AI matching
Get Intch if you'd like to
1130484 people
21
CEO / Leadership Coach / Career Strategist / Instructional Designer / Curriculum Consultant @ Expanding Leaders
15
Project Manager, Consultant
15
Production Assistant
139970 people
15
Business Development Manager @ Lewis Stevenson Office Solutions
20
IT Project Manager @ Innovos Consulting Group
29
Sales Coach & Consultant/VP of Sales