Manager, Pharmacovigilance - Remote Position

Primary Objective Of Position

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 post marketing.

• Perform periodic aggregate safety data review according to a signal detection strategy and elevate possible safety issues to AD Pharmacovigilance and Clinical/Medical Monitor as needed for assigned product(s).
• Define search criteria (e.g., PT, SMQs), run validated database searches, and analyze data for safety signal detection.
• Collaborate with PV lead in the preparation of DSURs, PSURs, PADERs, PBRERs as appropriate.
• Monitor medical and scientific literature for published articles relevant to the safety profile for assigned product(s).
• Plan and perform analysis in support of responses 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 for developing and updating Investigator Brochures and study protocols.
• Provide and present safety data analysis in support of Safety Review Committee (SRC).
• Collaborate with data management as needed, review data in Clinical database as part of signal management process to ensure appropriate safety reporting.
• Lead efforts to improve processes and increase work efficiency applicable to Pharmacovigilance.
• 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.
• Perform medical review of ICSR, query sites for additional information and collaborate with Clinical Operations as needed.
• Write narratives, review 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.

• Must have the ability to work independently 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 and assessment of safety data (pre and post marketing).
• Ability to critically analyze individual and aggregate safety data with scientific rigor.
• Proven ability to critically evaluate and summarize clinical and scientific data.
• Ability to create narrative summaries, safety analysis documents, and/or safety sections of regulatory documents.
• Demonstrate computer literacy with proficiency in the used and management of safety databases, strong computer skills such as Word, Power Point, and Excel.

• BS/BA degree in a health‑related (e.g., RN/BSN, RPh) or biological science field (e.g., B.S. in Biology), or an advanced degree (e.g., MD, Pharm
  
  D, PhD, PA) and a minimum of 3 years of biotech/pharmaceutical experience in Drug Safety/Pharmacovigilance.

• Minimum 3 years in Pharmacovigilance & Risk Management.
• Strong working knowledge of US/EU/AP/LA regulations, ICH, and GVP guidelines.
• 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 working in electronic document management systems.

• Experience with MedDRA, WHO, ARGUS safety database, and Veeva Safety database will be a plus.

This is a…