Duration:
6+ months- potential perm
Hours of operation:
M-F 9AM EST- 5PM EST, meetings with CRO in China weekly on Tuesday at 7pm EST, Note: there may be periodic meetings with CRO in China as well, and if those are scheduled, they will be in the AM also EST time.
Description:
The Safety Physician of Safety/Pharmacovigilance (PV) at Clinical Division will support the Chief Medical Officer in the oversight and monitoring of product safety related aspects of all programs developing appropriate SOPs to ensure trial conduction incompliance with regulatory requirements and directing team of risk and benefit management of study medication. This position reports to the Chief Medical Officer.
Responsibilities
- Responsible for the writing, auditing and revising the relevant documents for clinical trial projects;
Make clinical development plans, assist functional departments in providing medical strategies and medical support, maintain external expert relationships.
Develop proactive patient-centric risk management strategies for the product. - Full overall medical accountability for the benefit-risk and product risk minimization of activities for investigational compounds of Clinical Program.
- Plan, manage, analyze and monitor Safety/PV activities for study medications, including:
- Oversee CRO medical monitor or directly monitor study safety related activities.
- Set-up of safety analyses in the clinical trial and safety databases for monitoring
- Be accountable for serious adverse events (SAEs) review and safety report.
- Be responsible for safety issue management, discussion with the investigators and responses to safety-related questions from regulatory agencies and internal/external stakeholders, Investigators/IDMC meetings and Due Diligences, as needed.
- Provide clinical support for required regulatory submission, such as annual reports, DSUR, RMPs, PSUR, PBRER, IB, final study reports, analysis, and assessment of SUSARs and critical cases, detection of safety signals, summary of integrated safety and clinical overview statements.
- Provide interpretation of clinical trial safety data for clinical trial reports, publications, and submission documents.
- Develops departmental SOPs and works with Quality Assurance for compliance with applicable quality and regulatory requirements.
- Provide updates of the drug’s safety profile to Senior Management.
- Lead an internal Safety/PV monthly data review meeting and provide training/guidance to clinical team as needed.
- Provide updates of the drug’s safety profile to Senior Management.
- Contribute to process optimization as needed.
Requirements/ Qualifications
- Medical doctor with sound clinical or research experience.
- 10 or more years profound experience in Pharmacovigilance and Risk Management in pharmaceutical company or biopharma at a global/international level is preferred.
- Significant experience and knowledge of clinical development and post marketing regulation, interactions with regulatory agencies, regulatory submission experience.
- Sound knowledge of pharmacovigilance and safety for non-clinical and clinical development.
- Leadership and project management competencies.
- Related experience working in the Oncology target therapy is preferred.
- Excellent working knowledge of ICH, GCP and FDA/EMA guidelines/regulations.
- Exhibiting “can-do” attitude, “out-of-the-box” thinking and good attention to details.
- Excellent managerial, organizational and negotiation skills.
- Excellent verbal and written communication skills.
- Proven track record of success in a leadership role.
- Energetic individual, eager to manage multiple activities and priorities.
- Dedication to quality in all work tasks and deliverables in a timely manner.
- Flexibility working with global teams in different time zones. Able to travel per business request.
PLUS: if they can speak Mandarin that’s a plus but not required
Remote: PV Physician (MD) (233676)
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