Puma Biotechnology Inc. does not accept unsolicited resumes or candidates from outside staffing agencies or recruiters.
To provide proactive safety surveillance across the lifecycle of Puma products, Support development and execution of Risk Management Plans, Risk Assessment, and Risk Communications pre-and-postmarketing.
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 regulatory agencies, EC/IRBs and Investigators or ad hoc inquiries regarding safety issues
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 support of developing and updating Investigator Brochures and study protocols
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
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 & Abilities
Must have the ability to work independent in a fast-paced results-driven environment
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.
This is an in-house position. The physical demands of the office are normally associated with extended amounts of time in front of a computer. While performing the duties of this job, the employee is frequently required to stand, walk, and sit.
Up to 10% travel (if any)
Education & Professional Experience
Medical Degree (MD) and 3+ years of biotech/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 with ARISg, MedDRA, WHO, ARGUS safety databases will be a plus
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
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 office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; and talk or hear. The employee must occasionally lift or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.
Position Type/Expected Hours of Work
This is a full-time position. Days and hours of work are Monday through Friday, 8:00 a.m. to 5 p.m. This position regularly requires long hours.
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.
Equal Opportunity Employer
Puma Biotechnology Inc is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, ethnicity, age, disability, veteran status, marital status, or any other characteristic protected by law.