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Senior Manager, Pharmacovigilance & Epidemiology

Company: Apex Systems
Location: Santa Monica
Posted on: March 21, 2020

Job Description:

Job Description Job 1057376 Seeking a Senior Manager, Pharmacovigilance Epidemiology! 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), Participates in cross-functional teams (e.g., Working Groups, Committees, etc.), involving interactions with staff within and external to PVE, to ensure timely advancement of deliverables and submission to health authorities as required Support development andor maintenance of core and local label for products Contribute to preparing safety assessments reports Participate in preparing responses to safety related requests from health authorities Reviews draft periodic reports 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 PharmacovigilanceRisk 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 multi-functional 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. EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.

Keywords: Apex Systems, Santa Monica , Senior Manager, Pharmacovigilance & Epidemiology, Executive , Santa Monica, California

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