Senior Manager, Pharmacovigilance - Remote Position
Puma Biotechnology, Inc.
August 15, 2026
Remote
United States
Operations
Provide proactive safety surveillance and risk management across the lifecycle of marketed products, including monitoring, evaluating, and communicating product safety via clinical and post-marketing safety data analysis, aggregate safety reporting, signal detection, benefit-risk assessments, and risk management activities.
Major Duties / Responsibilities
- Perform periodic aggregate safety data review per signal detection strategy; escalate safety issues as needed.
- Support DSURs, PSURs, PADERs, PBRERs.
- Monitor medical/scientific literature for relevant safety signals.
- Define search criteria (e.g., PT, SMQs), run validated database searches, and analyze data for signal detection.
- Analyze safety data to respond to partner/regulatory/EC-IRB/investigator/ad hoc safety queries.
- Monitor SDEA/PVA with commercial partners.
- Support development/execution of risk management plans and risk communications.
- Support safety sections of regulatory documents and related materials (e.g., Informed Consent, Core Data Sheets, labels); support SRC.
- Manage day-to-day safety agreement activities with licensing/collaboration partners (CROs).
- Improve safety surveillance processes and efficiency; follow standard processes.
If Required
- Triage ICSRs for causality assessment; write SAE narratives; ensure clinical content accuracy/completeness.
- Create follow-up queries and case follow-up measures; ensure compliant safety reporting.
Skills/Abilities
- Independent, detail-oriented in fast-paced environment; ability to make basic AE/coding decisions.
- Information-seeking/problem-solving; strong interpersonal and communication skills.
- Proficient in pre/post-marketing safety data processing; ability to critically evaluate/summarize clinical/scientific data.
- Computer literacy; safety database proficiency; Word/PowerPoint/Excel.
Required Education/Experience
- Advanced degree (MD, RN/BSN, RPh/PharmD) + 4+ years PV/Drug Safety, or BS in health/biology + 6+ years.
- 3–5 years PV & Risk Management.
- Experience with adverse event reporting systems; FDA/EU drug safety requirements.
- Phase I–IV drug safety surveillance; preparation of investigational and post-marketing regulatory reports.
- Safety database experience (Argus, Veeva Vault Safety) and coding with MedDRA/WHO.
Preferred
- Advanced degree + 5+ years (or BS + 7+ years); 4–6 years PV & Risk Management.
- Safety surveillance and post-marketing report preparation; Argus/Veeva + MedDRA/WHO.
Compensation/Benefits
- Salary range: $150,000–$175,000/year; includes competitive base salary, annual bonus target, and robust benefits package.
Major Duties / Responsibilities
- Perform periodic aggregate safety data review per signal detection strategy; escalate safety issues as needed.
- Support DSURs, PSURs, PADERs, PBRERs.
- Monitor medical/scientific literature for relevant safety signals.
- Define search criteria (e.g., PT, SMQs), run validated database searches, and analyze data for signal detection.
- Analyze safety data to respond to partner/regulatory/EC-IRB/investigator/ad hoc safety queries.
- Monitor SDEA/PVA with commercial partners.
- Support development/execution of risk management plans and risk communications.
- Support safety sections of regulatory documents and related materials (e.g., Informed Consent, Core Data Sheets, labels); support SRC.
- Manage day-to-day safety agreement activities with licensing/collaboration partners (CROs).
- Improve safety surveillance processes and efficiency; follow standard processes.
If Required
- Triage ICSRs for causality assessment; write SAE narratives; ensure clinical content accuracy/completeness.
- Create follow-up queries and case follow-up measures; ensure compliant safety reporting.
Skills/Abilities
- Independent, detail-oriented in fast-paced environment; ability to make basic AE/coding decisions.
- Information-seeking/problem-solving; strong interpersonal and communication skills.
- Proficient in pre/post-marketing safety data processing; ability to critically evaluate/summarize clinical/scientific data.
- Computer literacy; safety database proficiency; Word/PowerPoint/Excel.
Required Education/Experience
- Advanced degree (MD, RN/BSN, RPh/PharmD) + 4+ years PV/Drug Safety, or BS in health/biology + 6+ years.
- 3–5 years PV & Risk Management.
- Experience with adverse event reporting systems; FDA/EU drug safety requirements.
- Phase I–IV drug safety surveillance; preparation of investigational and post-marketing regulatory reports.
- Safety database experience (Argus, Veeva Vault Safety) and coding with MedDRA/WHO.
Preferred
- Advanced degree + 5+ years (or BS + 7+ years); 4–6 years PV & Risk Management.
- Safety surveillance and post-marketing report preparation; Argus/Veeva + MedDRA/WHO.
Compensation/Benefits
- Salary range: $150,000–$175,000/year; includes competitive base salary, annual bonus target, and robust benefits package.