RETAINED SEARCH: Director, US Drug Safety/PV Operations; (Top U.S. PV role); Start-up US Group; Innovative Biotech
Unique & Attractive Features about this Opportunity:
- Leadership: Serve as the local safety and PV leader internally, and as PV point of contact/ Subject-Matter-Expert to HQ and to FDA.
- Relationships: Create, build and maintain relationships with key strategic internal stakeholders and external stakeholders (FDA).
- New Treatment: Work with first-in class immunological therapies with diverse modalities.
- Save Lives for an Unmet Need: Contribute significantly to finding safe, effective, and patient-friendly, immunological therapies for patients.
- Lead efforts to build and implement local U.S. pharmacovigilance systems fully compliant with FDA and U.S. regulations.
- Work with HQ in implementation of new ARISg database to be independent and have full access to, as well as have responsibilities of investigator reporting for local studies.
- Will be the point-of-contact for local U.S. authorities; readiness for FDA inspections as well as training local pharmacovigilance team and further all subsidiary personnel on essential PV requirements.
- Responsible of the management of local vigilance cases reported during local clinical trials, during named patient use , in the post marketing setting, spontaneously or in the context of non-interventional studies, or of local cases registered from non-company sponsored trials (IIT) or expanded access program in agreement with contract provisions.
- Ensure all local risk management and minimization strategies are in place in agreement with core management strategies implemented by the Global Safety & PV department and ensure assessment of the effectiveness of risk minimization measures.
- Reports promptly all requests related to safety received from local HA, health care professionals, consumers association and ensures that comprehensive and appropriate answers are reviewed, finalized and sent to the enquirer within suitable timelines.
- Ensures appropriate coordination is in place with the following functional activities: QA, medical, clinical, medical information, regulatory activity, marketing, legal, sales representatives, MSLs, and any other local function which needs support from vigilance or which activity has an impact on vigilance.
- Prepares local periodic reports; submits these reports within the appropriate timelines according to national regulations. Ensures submission, either directly or through CRO of periodic safety reports and any other reports (as applicable) which are prepared by the corporate in accordance with the local regulations.
- Finalize the work with U.S. Medical Information team, and in parallel to work on authoring local SOPs.
- Interact seamlessly with HQ Corporate on sharing local reporting, follow-up on REMS activities, and post-marketing studies.
- Finalize Medication Guide for the U.S and the US PI and participate in answering FDA comments on these documents during review of the dossier.
- 5+ years’ experience of implementing pharmacovigilance processes within the pharmaceutical, or drug/device industry.
- PharmD, PhD, or equivalent degree required.
- Experience in interacting with FDA in context of submitting proper safety documentation and serving as the Safety/PV Lead for inspections; up-to-date knowledge of US safety regulations and guidelines, in support of both clinical development and post-marketing areas.
Lavinia Rodriguez | Recruiting Consultant
CORNERSTONE SEARCH GROUP, LLC – www.cornerstonesg.com
Life Sciences Executive Search
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