Senior Medical Director, Product Safety Physician Lead
New
B
BeOnePharmaceutical oncology
Remote (US)Full-TimeDirector
Salary$298,200.00 - $368,200.00 annually
Apply NowOpens the employer's application page
Job Details
- Experience
- 6 + years’ pharmaceutical/biotechnology industry experience in Clinical Research, Clinical Development and 4 + years' experience in safety in Phase 1 and Phase 2
- Required Skills
- Microsoft ExcelPowerPoint
Requirements
- Hold an MD or internationally recognized equivalent and complete an accredited residency.
- Have 6+ years of pharmaceutical or biotechnology industry experience in Clinical Research or Clinical Development.
- Have 4+ years of safety experience in Phase 1 and Phase 2.
- Have prior experience as a product safety physician.
- Have prior matrix management team experience.
- Have pharmaceutical product development experience, including individual study design and filing plans.
- Have experience with global regulatory requirements for pharmacovigilance.
- Have experience interacting with regulatory agencies and key opinion leaders.
- Demonstrate intermediate knowledge of a safety database for retrieving safety information.
- Have advanced knowledge of MedDRA and advanced application capability with Excel, PowerPoint, and Word.
- Be familiar with data-mining and exploratory analysis tools such as Spotfire.
- An accredited fellowship with one year of clinical patient experience in a relevant therapeutic specialty is preferred; oncology preapproval experience is also preferred.
Responsibilities
- Oversee the benefit-risk safety profile of assigned products throughout the product life cycle, with a focus on early development.
- Lead identification, assessment, escalation, and management of safety concerns for developmental and approved products.
- Chair Safety Management Team meetings and represent product safety perspectives in company safety governance.
- Lead safety communications and coordinate safety recommendations with labeling groups, regulatory affairs, and other stakeholders.
- Develop and manage strategies, documentation, and responses for safety issues and regulatory inquiries.
- Guide safety content and review activities for clinical trial protocols, investigator brochures, informed consent forms, safety monitoring plans, and data capture.
- Review safety data, serious adverse events, abnormal laboratory results, and aggregate safety analyses for assigned programs.
- Lead pharmacovigilance processes and develop and maintain product safety strategies, surveillance plans, and safety profiles.
- Train and mentor Safety Physicians and Safety Scientists and coordinate product safety work across global patient safety teams.
View Full Description & ApplyYou'll be redirected to the employer's site
