What are the responsibilities and job description for the Medical Director/Sr Medical Director position at ClinLab Staffing?
Medical Director / Sr Medical Director, Drug Safety & Pharmacovigilance
Remote
Reporting to the Vice President, Pharmacovigilance, the Medical Director / Sr Medical Director, Drug Safety & Pharmacovigilance will lead a variety of core medical safety activities within the PV organization to support the monitoring and evaluation of the safety profile of assigned products. This position requires an experienced and accomplished safety physician who can provide medical and PV expertise while collaborating with multiple stakeholders, including clinical development, biostatistics, clinical operations and medical affairs. The role will oversee the outsourced PV case processing and medical review, as well as the clinical trial medical monitoring activities for the ongoing and planned Phase 3 clinical trials executed by the CRO.
Responsibilities (including, but not limited to) :
- Provide medical and scientific expertise in all aspects of Drug Safety and Pharmacovigilance, including contribution to the ongoing worldwide signal detection monitoring, product risk-benefit assessment, and safety assessment activities of assigned products / indications.
- Lead preparation for and running of quarterly Safety Management Team meetings for assigned programs, including the analysis of clinical trial data, non-clinical data, literature reports and competitive intelligence.
- Assist the Vice President, Pharmacovigilance in implementing the overall clinical strategy for lead programs from development, through regulatory submissions and post-commercialization, with an emphasis on mid to late stages of development and commercial products.
- Design and implement safety strategy for clinical studies, including regular review of safety data and responses to safety issues.
- Assist in clinical data review, analysis, and interpretation from a variety of sources to enable program go / no-go decisions.
- Assist in the review of study documents and protocols, regulatory materials, and interpret clinical study data.
- Coordinate safety outputs from the clinical and safety database for signaling activities and for ad hoc requests.
- Contribute to IB and RSI creation and its revisions.
- Accountable for Aggregate Report coordination including scheduling, planning, management of preparation activities, and drafting of assigned safety portions.
- Collaborate with appropriate clinical, medical, quality, and regulatory counterparts and others across the business, to provide input and oversight for all safety and PV issues, including contributing authorship and review of Investigator Brochures, DSURs, development plans, clinical protocols, INDs / CTAs, regulatory responses, and risk management plans.
- Coordinate and participate in the development of ad-hoc Health Authority responses.
- Review SAEs and SUSARs, assure outputs from the safety database as well as timely completion of the Analysis of Similar Event Summaries for HA submissions.
- Liaise effectively within Pharmacovigilance and with other cross-functional departments.
- Monitors safety risk minimization measures.
- Assist in covering the needs of medical affairs by helping lead the continued development and execution of a Medical Affairs strategy, including external stakeholder management, communication, patient identification, evidence generation , publications, and medical education.
- Perform other duties as assigned.
Qualifications :
