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Senior Manager, Pharmacovigilance & Epidemiology (PVE), Risk Management

Company: LeadStack Inc.
Location: Santa Monica
Posted on: March 26, 2020

Job Description:

Title: Senior Manager, Pharmacovigilance & Epidemiology (PVE), Risk Management - Cellular Therapy -- Responsibilities (include but are not limited to):-- --- -- -- -- -- -- Support preparation and maintenance of Risk Management plans --- -- -- -- -- -- Contributes to development and execution of Risk Evaluation and Mitigation Strategy (REMS), including the associated Elements to Assure Safe Use (ETASU), as applicable --- -- -- -- -- -- Participates in cross-functional teams (e.g., Working Groups, Committees, etc.), involving interactions within and external to PVE, to ensure timely advancement of deliverables and submission to health authorities as required --- -- -- -- -- -- Support development and/or maintenance of core and local label for products (e.g., CDS, USPI, SmPC, IB, etc) --- -- -- -- -- -- Contribute to preparing safety assessments reports --- -- -- -- -- -- Participate in preparing responses to safety related requests from health authorities --- -- -- -- -- -- Reviews draft periodic reports (e.g., PSUR/PBRER, PADER, DSUR, etc.); may author relevant sections as needed -- Requirements:-- --- -- -- -- -- -- Bachelor's level degree in life sciences required; MD, PharmD or PhD highly preferred. --- -- -- -- -- -- At least 5 years of direct Pharmacovigilance/Risk Management is required. --- -- -- -- -- -- Solid knowledge of FDA, EMA, and ICH safety reporting regulations and GVP guidelines. --- -- -- -- -- -- Strong knowledge of safety database (preferably ARGUS), MedDRA, and WHO Drug --- -- -- -- -- -- Strong quality focus, with a good understanding of quality systems. --- -- -- -- -- -- Excellent communicator, both oral and written, specifically medical writing skills --- -- -- -- -- -- Ability to critically analyze individual and aggregate safety data with scientific rigor --- -- -- -- -- -- Previous experience in preparing periodic safety reports and risk management plans --- -- -- -- -- -- Strong relationship building skills, with ability to interact effectively in a multifunctional and multicultural team setting --- -- -- -- -- -- Excellent written and verbal communication skills to a variety of levels and teams, internally and externally. --- -- -- -- -- -- Demonstrated persuasion, influencing and negotiation skills --- -- -- -- -- -- Ability to operate objectively and independently as a leader and as a member of a team, as required --- -- -- -- -- -- Effective team player, with proven ability to effectively lead projects and teams to successful conclusion.

Keywords: LeadStack Inc., Santa Monica , Senior Manager, Pharmacovigilance & Epidemiology (PVE), Risk Management, Executive , Santa Monica, California

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