Virtus Healthcare Staffing, LLCBoston, 12 mi from Burlington (MA)
Trusted Staffe Seeks Director of Risk Management for Level I Trauma Center
Trusted Staffe is partnering with a Level I trauma center to find a qualified and experienced Director of Risk Management. This is an exceptional opportunity for a leader...
SGA Inc.Boston, 12 mi from Burlington (MA)
Software Guidance & Assistance, Inc., (SGA), is searching for an IT Compliance & Risk Management Specialist for a CONTRACT assignment with one of our premier Financial Services clients in Boston, MA.
Responsibilities:
Perform IT compliance, risk...
Booz Allen HamiltonLexington
Cloud Application Migration Project Manager. As an Application Migration Program Manager, you know how to take advantage of cloud. Experience with project management tools, including Jira, Trello, or Asana. Knowledge of project management methodologies, including Agile, Waterfall, and DevOps.
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AKIMABoston
The Program Manager leads project workstreams for a complex Air Force Enterprise IT modernization effort that delivers Software-Defined Wide Area Network (SD-WAN) and Secure Access Service Edge (SASE) solutions. Act as the single point of contact for all SD-WAN and SASE Original Manufacturers (OEMs)...
Abacus Technology CorporationHanscom Air Force Base
Knowledge of support activities that assist the program manager in assessing what programs are within schedule and cost baselines, be able to recommend viable solutions to problems, and the pursuit of alternative courses of action. Abacus Technology is seeking a Program Manager to provide acquisitio...
Booz Allen HamiltonLexington
Technical Program Manager, Lead. Design, implement, and maintain strategic, multi-disciplinary IT programs in support of corporate strategy. Knowledge of establishing and documenting repeatable programmatic and te. Our offerings include health, life, disability, financial, and retirement benefits, a...
Capital OneCambridge, 9 mi from Burlington (MA)
West Creek 4 (12074), United States of America, Richmond, Virginia
Senior Manager, Generative AI Risk Management (ES Risk)
Do you want to join a highly collaborative team that's dedicated to making risk management a competitive advantage...
Fidelity TalentSource LLCBoston, 12 mi from Burlington (MA)
years industry experience, including audit or financial services risk management.
• Knowledge of accounting practices and financial services industry.
• Fund accounting and operations knowledge, specifically related to alternative investments, preferred...
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Senior Manager, Pharmacovigilance and Risk Management
Waltham (MA) | www.resume-library.com |
Job Description
The Associate Director/Senior Manager, Pharmacovigilance and Risk Management, serves as a critical medical and data analytical role for the assigned investigational and/or marketed product(s). The successful candidate is expected to be equally effective working independently as well as collaboratively.
She/he must possess knowledge and skills to ensure that safety data analyses and reports are of high quality and in adherence to requirements and regulatory timelines. Accountability in leading and managing projects as well as ability to analyze, interpret, and effectively communicate data is a key success factor for this role.
The position may be filled at the Associate Director or Senior Manager level and will report to the Pharmacovigilance Risk Management Lead in Waltham, MA.
What You’ll Do:
Serve as the analytical safety lead for the assigned program(s)/product(s).
Responsible for signal management, including signal detection, signal investigation, and preparation of signal evaluation reports, including input into a design of a comprehensive safety surveillance system.
Review data outputs and literature, interpret and communicate findings.
Analyze data for aggregate safety reports (e.g., DSURs, PADERs, PBRERs), and ad-hoc regulatory requests.
Support Risk Management Plan (RMP) related activities.
Participate in regulatory submission activities (NDA, MAA) and support ad-hoc query responses to health authorities.
The Associate Director/Senior Manager, Pharmacovigilance and Risk Management, serves as a critical medical and data analytical role for the assigned investigational and/or marketed product(s). The successful candidate is expected to be equally effective working independently as well as collaboratively.
She/he must possess knowledge and skills to ensure that safety data analyses and reports are of high quality and in adherence to requirements and regulatory timelines. Accountability in leading and managing projects as well as ability to analyze, interpret, and effectively communicate data is a key success factor for this role.
The position may be filled at the Associate Director or Senior Manager level and will report to the Pharmacovigilance Risk Management Lead in Waltham, MA.
What You’ll Do:
Serve as the analytical safety lead for the assigned program(s)/product(s).
Responsible for signal management, including signal detection, signal investigation, and preparation of signal evaluation reports, including input into a design of a comprehensive safety surveillance system.
Review data outputs and literature, interpret and communicate findings.
Analyze data for aggregate safety reports (e.g., DSURs, PADERs, PBRERs), and ad-hoc regulatory requests.
Support Risk Management Plan (RMP) related activities.
Participate in regulatory submission activities (NDA, MAA) and support ad-hoc query responses to health authorities.
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