Senior Manager, Pharmacovigilance - Remote Position

About the role

Puma Biotechnology Inc. does not accept unsolicited resumes or candidates from outside staffing agencies or recruiters.

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)
• Collaborate 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
• 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

Requirements

• 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.
• Must have the ability to work independent in a fast-paced results-driven environment with attention to details
• 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

Qualifications

• 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 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

Skills

• Ability to work independent in a fast-paced results-driven environment with attention to details
• 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

Benefits

Higher compensation may be available for someone with advanced skills and/or experience.

Pay

$150,000 - $175,000 per year

Schedule

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.