Our client, a biopharmaceutical company based in West Los Angeles needs to hire a Manager of Global Pharmacovigilance on a full time, regular hire basis. This company has experienced tremendous success with its oncology drugs in clinical trials and is ready to integrate resources with a Pharmacovigilance background into the company. You will provide proactive safety surveillance across the lifecycle of their products, support development, and execution of risk management plans, risk assessment and risk communications.

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 Monitor as needed for assigned product(s)

• Generate periodic aggregate safety reports for assigned product(s)

• Monitor medical and scientific literature for published articles relevant to the safety profile for ssigned 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 Monitor

• Plan and perform analysis in support of response to regulatory, EC/IRBs and Investigators or ad hoc inquiries regarding safety issues

• Conduct safety data analysis in support of developing and updating safety sections of regulatory documents, informed consent, annual reports, 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 with partners (CRO’s)

• Lead efforts to improve processes and increase work efficiency applicable to the Safety Surveillance

• Remain in compliance with active Client 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

Required Skills:

• Masters degree plus 3 - 5 years of biotech/pharmaceutical experience OR Doctoral degree/Nursing degree and 3+ years of biotech/pharmaceutical experience in drug safety/pharmacovigilance

• Previous experience with adverse event reporting systems, FDA and EU drug safety/Pharmacovigilance requirements

• Ability to make basic decisions (e.g., categorizing serious and non-serious adverse events, routine coding) with an understanding of the result and impact

• Proficiency in the processing, assessment of safety data