NewarkRecruiter Since 2001
the smart solution for Newark jobs

`Medical Director Medical Safety Evdaluation

Company: Robsco Search
Location: Newark
Posted on: November 20, 2020

Job Description:

Medical Director, Medical Safety Evaluation (MSE) The Medical Director Medical Safety Evaluation (MSE) is responsible for the management of the Medical Safety Evaluation Office of global products throughout the product lifecycle within the Global Drug Safety and Evaluation Center (GDSEC). Incumbent implements corporate policies to ensure the safety of the product in global development portfolio. The Medical Director is accountable for providing medical input to the assessment of the safety profile for each drug and for appropriate and timely regulatory reporting of safety issues. Responsibilities: Leads overall medical safety evaluation for global investigational products and clinical development program. Participates in FDA or other health authority safety interactions/responses with support from his/her manager. Has full accountability for all aspects of the global drug safety function, including development/delivery of a quality Pharmacovigilance system for assigned products/activities. Is theprimary safety representative between global/local groups and external groups (Drug Safety Monitoring Boards, regulatory agencies, physician communities, external experts, and CROs) on product safety related issues. Leads safety signal detection activities and global cross functional safety teams, with appropriate communication/escalation (eg label/IB updates).Oversees/conducts signal tracking for products according to regulatory requirements and corporate business strategy. Completes/reviews medical assessments of safety data [Periodic Safety Update Reports (PSURs, DSUR), Safety Statements, Safety Surveillance Plans, and Discussion Documents; as appropriate) and ensures the benefit/risk information is accurate. Oversees development and preparation of Risk Management Actions Plans for regulatory filings. Interacts extensively with regional and corporate departments to provide medical/drug safety input to clinical research (scientific and operational), MTDA regulatory affairs, and global quality/manufacturing. Works with cross-functional commercial teams to build awareness of the safety of company products in the medical community, including supporting company sponsored Advisory Boards, participating in medical symposia, publishing, attending media events, and other activities. Oversees data collection, processing, assessment, and preparation of case reports, annual reports, and periodic reports to ensure the timely submission to international regulatory agencies. Provides overview of the safety aspects of the planning, execution, data collection and interpretation of clinical research.Performs medical review/approval of medically coded safety data, including adverse events, medical history and concomitant medications. Accountable for the performance and results of the Drug Safety department and provides medical advice, training, and support. Implements department plans and priorities to address business and operational challenges. Develops and implements strategies for Pharmacovigilance business plans in accordance with long-term company strategic plans. This includes active involvement and coordination with local and international Pharmacovigilance directors and physicians. Supports the development of a Global Pharmacovigilance Team that is fully compliant with all local regulatory requirements.Improves organizational efficiency through outsourcing and other alliances. Provides input to senior management, as requested, regarding safety aspects of brand strategy, key messages, data review, and future data needs. Performs other departmental duties as assigned. Qualifications Medical Degree (MD or DO); current medical license preferred Board Certification or equivalent in a medical specialty and significant clinical experience desired Minimum of 3+ years pharmacovigilance/safety physician experience US clinical practice experience preferred Exposure or experience writing pharmaceutical regulatory or clinical research documents, including periodic safety reports and risk management plans Post-graduate training in clinical epidemiology and biostatistics is also desirable Strong interpersonal skills and ability to collaborate effectively with other groups in a matrix organization Familiarity with US and International Safety reporting regulations and guidelines (in particular, ICH clinical safety guidelines) Exposure or experience in Phase I-III trials, especially with key activities (e.g. SMMP, CRO interaction, Safety-Clinical Database reconciliation, expedited reporting, AOSE, IND update, AR, ISS) Exposure or experience in post-marketing/phase IV studies and surveys with key activities (e.g. patient registries, survey protocols) Contributor for PSUR, RMP, and DSUR documents Exposure or experience with safety databases Willingness to travel domestically and internationally typically 20%

Keywords: Robsco Search, Newark , `Medical Director Medical Safety Evdaluation, Executive , Newark, New Jersey

Click here to apply!

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

I'm looking for
in category
within


Other Executive Jobs


Account Manager
Description: Job Description br br Job Title:Account Manager br br FLSA Status:Exempt br br Department:Sales br br Summary br br The Account Manager is responsible for selling and presenting Varonis (more...)
Company: Varonis
Location: New York
Posted on: 11/26/2020

Sr. Associate, Cyber Security - Enterprise Identity Access Management
Description: The KPMG Advisory practice is currently our fastest growing practice. We are seeing tremendous client demand, and looking forward we don't anticipate that slowing down. In this ever-changing market environment, (more...)
Company: KPMG
Location: New York
Posted on: 11/26/2020

Sr.Product Marketing Manager
Description: Position:Sr.Product Marketing ManagerJob Description:Summary:The position is liaison between Arrow's suppliers and Arrow sales team. The main purpose of the position is to develop, grow and leverage the (more...)
Company: Arrow Electronics
Location: New York
Posted on: 11/26/2020


Computer Systems Security Manager (New York,NY)
Description: Are you interested in bringing your talents to the forefront of innovation and excellence Please join us for our Career Talks
Company: National Security Agency
Location: New York
Posted on: 11/26/2020

Manager, Warehouse
Description: br br Company Overview Previously known as HD Supply - Construction Industrial and now known as White Cap Supply Holdings, Inc., we are made up of three distinct businesses called White Cap, Contractors' (more...)
Company: White Cap
Location: Woodside
Posted on: 11/26/2020

Finance Director
Description: Position OverviewMSCI is seeking a Finance Director to lead the financial management for the Analytics Product line. MSCIs Analytics products offer institutional investors an integrated view of risk and (more...)
Company: MSCI Inc.
Location: New York
Posted on: 11/26/2020

Manager, Software Engrg
Description: Description: Job Title Manager, Software Engrg Job Location Clifton, NJ Job ID CS20203009-51228Job Description:--The Engineering Manager is required to perform the following department leadership (more...)
Company: L3Harris Technologies
Location: Hollis
Posted on: 11/26/2020

RN Care Management Supervisor
Description: Job DescriptionThe challenges of affordable healthcare continue to create new opportunities. Elderplan and HomeFirst, our Medicare
Company: MJHS
Location: New York
Posted on: 11/26/2020

Database Manager - Virtual Career Fair (New York,NY)
Description: Are you interested in bringing your talents to the forefront of innovation and excellence Please join us for our Career Talks
Company: National Security Agency
Location: New York
Posted on: 11/26/2020

Case Manager
Description: Job Description br br br Job ID :2302 br br br br Job Category:Transitional Housing br br br br Position Type:Full Time br br br br Details: br br br br br br (more...)
Company: Acacia Network
Location: New York
Posted on: 11/26/2020

Log In or Create An Account

Get the latest New Jersey jobs by following @recnetNJ on Twitter!

Newark RSS job feeds