Provide proactive safety surveillance and risk management across the lifecycle of Puma's marketed products. The role is responsible for monitoring, evaluating, and communicating product safety information through ongoing analysis of clinical and post-marketing safety data, supporting aggregate safety reporting, signal detection, benefit-risk assessments, and risk management activities. This position collaborates with cross-functional teams and external partners to ensure compliance with global pharmacovigilance regulations while helping to protect patient safety and maintain the overall benefit-risk profile of Puma products.

Major Duties / Responsibilities

• Perform periodic aggregate safety data review according to a signal detection strategy and escalate possible safety issues to VP of Global Pharmacovigilance and Clinical/Medical Monitor as needed for assigned product(s)
• Collaborates with PV leader in the preparation DSURs, PSURs, PADERs, PBRERs as appropriate
• Monitor medical and scientific literature for published articles relevant to the safety profile for assigned product(s)
• Define search criteria (e.g., PT, SMQs), run validated database searches, and analyze data for safety signal detection in consultation with VP Pharmacovigilance and/or Clinical/Medical Monitor
• Plan and perform analysis in support of response to queries from commercial partners, regulatory agencies, EC/IRBs Investigators or ad hoc inquiries regarding safety issues
• Monitor Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) with commercial partners
• Support development and execution of risk management plans, risk assessment, and risk communications
• Conduct safety data analysis in support of developing and updating safety sections of regulatory documents, Informed Consent, Company Core Data Sheets, product labels, etc.
• Provide safety data analysis in support of Safety Review Committee (SRC)
• Manage the relevant day-to-day aspects of safety agreement with licensing and/or collaboration partners (CRO's)
• Lead efforts to improve processes and increase work efficiency applicable to the Safety Surveillance
• Remain in compliance with active Puma standard processes and procedures

If required:

• Execute triage for appropriate causality assessment on Individual Case Safety Report (ICSRs) for regulatory reporting
• Write narratives, review of SAE for clinical content, accuracy and completeness
• Create follow-up queries, and case follow-up measures for case processing
• Manage and ensure compliant safety reporting in accordance with local and international reporting regulations, and/or standard operating procedures

Skills and Abilities

• Must have the ability to work independent in a fast-paced results-driven environment with attention to details
• Ability to make basic decisions (e.g., categorizing serious and non-serious adverse events, routine coding) with an understanding of the result and impact
• Proven ability to seek and utilize information and solve complex problems
• Excellent interpersonal skills in developing effective relationships with safety data customers and colleagues, with the ability to communicate with diverse individuals and groups
• Proficiency in the processing, assessment of safety data (pre-and-postmarketing)
• Proven ability to critically evaluate and summarize clinical and scientific data
• Demonstrated computer literacy, with proficiency in the used and management of safety databases, strong computer skills such as Word, Power Point, and Excel.

Required Education and Professional Experience

• Advanced degree in health-related discipline (i.e., MD, RN/BSN, RPh/PharmD) with 4+ years of biotechnology or pharmaceutical experience in Drug Safety/Pharmacovigilance; or Bachelor's degree in a health-related or biological science discipline (e.g., Biology or related field) with 6+ years of biotechnology or pharmaceutical experience in Drug Safety/Pharmacovigilance.
• 3-5 years in Pharmacovigilance & Risk Management
• Previous experience with adverse event reporting systems, FDA and EU drug safety/Pharmacovigilance requirements
• Experience in phase I-IV drug safety surveillance and preparation of investigational and post-marketing regulatory reports
• Experience in working on safety databases, i.e., Argus, Veeva Vault Safety, and coding using MedDRA and WHO, dictionaries.

Preferred Education and Experience

• Advanced degree in health-related discipline (i.e., MD, RN/BSN, RPh/PharmD) with 5+ years of biotechnology or pharmaceutical experience in Drug Safety/Pharmacovigilance; or Bachelor's degree in a health-related or biological science discipline (e.g., Biology or related field) with 7+ years of biotechnology or pharmaceutical experience in Drug Safety/Pharmacovigilance.
• 4-6 years in Pharmacovigilance & Risk Management
• Previous experience with adverse event reporting systems, FDA and EU drug safety/Pharmacovigilance requirements
• Experience in safety surveillance and preparation of post-marketing regulatory reports
• Experience in working on safety databases, i.e., Argus, Veeva Vault Safety, and coding using MedDRA and WHO, dictionaries.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Position Type/Expected Hours of Work

This is a full-time position. Days and hours of work are Monday through Friday, approximately 8:30 AM to 5 PM, depending on the schedule for the day. This position occasionally requires working outside of these hours and may extend to evenings and weekends as business needs require.

Work Environment

This position operates in a professional, virtual environment, working from a remote location, usually the employee's home.

Travel

The role requires infrequent travel. Minimal travel may be required for meetings and/or conferences, up to 5%.

Physical Demands

This is a remote position with employees working from a home office. The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position. The physical demands of the home office are normally associated with extended amounts of time sitting and using office equipment (including a computer, keyboard, and mouse), standing, walking, sitting, speaking, and hearing. The employee must occasionally lift or move up to 25 pounds.

Compensation Range

The salary range for this role is $150,000 - $175,000 per year. Higher compensation may be available for someone with advanced skills and/or experience.

At Puma Biotechnology, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), an annual bonus target, and a robust benefits package. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

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