SantaMonicaRecruiter Since 2001
the smart solution for Santa Monica jobs

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Accounting Manager
Description: The Manager, Accounting will be managing all aspects of the general ledger and the monthly close, as well as certain functions related to financial reporting. This includes, but is not limited to, reviewing (more...)
Company: Avanir Pharmaceuticals
Location: Aliso Viejo
Posted on: 04/10/2020

Home Care Manager
Description: The Home Care Supervisor oversees coordination and administration of all aspects of our Home Visit Program. This includes oversight of scheduling, staffing and leading the Home Visit Program. br Leadership: (more...)
Company: Wider Circle
Location: Lynwood
Posted on: 04/10/2020

Sr Project Manager
Description: JOB SUMMARY The purpose of this position is to manage and lead a staff responsible for individual, multi-disciplined real estate project solutions for clients, with direct accountability for project delivery.Characteristics (more...)
Company: CBRE
Location: Newport Beach
Posted on: 04/10/2020

Manager Test Engineering 1
Description: At Northrop Grumman, our employees have incredible opportunities to work on revolutionary systems in air and space that impact people's lives around the world today, and for generations to come. Our work (more...)
Company: Northrop Grumman
Location: Redondo Beach
Posted on: 04/10/2020

Director, Product Management - Subscriber Lifecycle
Description: Hulu is the leading premium streaming service offering live and on-demand TV and movies, with and without commercials, both in and outside the home. Operating at the intersection of entertainment and (more...)
Company: Hulu
Location: Santa Monica
Posted on: 04/10/2020

Operational Excellence Manager
Description: We are seeking a highly motivated individual to join us as a Manager, Operational Excellence. Reporting to the Director, Business Excellence, you will manage and oversee aspects of the Corporate OE effort (more...)
Company: Rangam
Location: Santa Monica
Posted on: 04/10/2020

Alternatives Funds Tax Manager
Description: br br br General Information br br br br Ref : 27750 br br Employee Type: Full Time br br Location: Newport Beach br br Date published: 29-Oct-2019 br br br br br (more...)
Company: PIMCO
Location: Newport Beach
Posted on: 04/10/2020

Clinical Manager, RN - Focus Home Health Stockton, $10K Sign - on
Description: US Job ID: 2020-20210 Job Code: 4434 Facility: West Region Category: Nursing Overview Covenant Care encompasses three business lines that are an integral part of a patient's continuum of care and
Company: Covenant Care California
Location: Aliso Viejo
Posted on: 04/10/2020

POS Systems Manager
Description: Job DescriptionPURPOSEProvides daily operational support related to restaurant technology needs.DUTIES RESPONSIBILITIES ul li Ensures POS Systems are always up and operational. li Monitors, resolves, (more...)
Company: Xperience Restaurant Group
Location: Cypress
Posted on: 04/10/2020

Maintenance Manager
Description: Job Type: Exempt br State::CA City:Camarillo br Brand:Avalon br br Overview AvalonBay is proud to be named one of Glassdoor's Best Places to Work in 2019. br br Creating a better way to liveis (more...)
Company: Avalonbay Communities
Location: Camarillo
Posted on: 04/10/2020

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Santa Monica RSS job feeds