Manager, Product Management - Corporate Surveillance Job at Capital One (New York)

Manager, Drug Safety Physician, Pharmacovigilance Epidemiology & Risk Management

Location

India , Noida

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Degree in Medicine
Minimum 3 years of relevant experience in Pharmacovigilance & Drug Safety
Strong interpersonal and organizational skills
High sense of responsibility, dedication, and desire to work under pressure
Highly service oriented
Good communication skills
Fluent in English- spoken and written
Previous exposure to corporate environment, pharma and life sciences industry is an advantage
PG degree in any discipline is an advantage but not mandatory

Job Responsibility

Conduct Medical Review and assessment of ICSR’s into the safety database
Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA codlings, suspect drugs, concomitant medications, lab data, medical history, labelling, causality, review narrative and provide Company Clinical Comment
Review and respond to any queries/comments from the case owner in the patient safety database
Screening of scientific literature by using the internal search mechanism or by making use of external tools and providers
Maintain strong GPVP and GCP knowledge
Following ICH and EMA guidelines strongly and implementing them appropriately
Train and mentor PV associates on event capturing and general PV conventions as required
Acquire and maintain current knowledge of product and safety profiles for products across therapeutic areas
Escalate complex case issues on client products to Team Lead/Line Manager
Medical triage and Identification (Classification of references) of safety-relevant publications in scientific literature

Fulltime

Avp Investment Portfolio Manager

Oversee and manage outsourced investment mandates for Sammons Financial Group As...

Location

United States , West Des Moines; Chicago

Salary:

160449.00 - 267415.00 USD / Year

Sammons Financial Group

Expiration Date

Until further notice

Requirements

Bachelor's Degree in Finance or related field preferred
Minimum 10 years' of institutional investment, credit market, portfolio management, external manager oversight, insurance asset management, manager research, outsourced chief investment officer (OCIO), investment consulting, or related experience required
Experience conducting investment manager due diligence, performance oversight, and portfolio risk analysis required
Strong knowledge of fixed income markets, corporate credit analysis, portfolio risk management, benchmark-relative performance, and institutional investment governance required
Experience collaborating across investment, finance, risk, accounting, actuarial, legal, compliance, tax, operations, or other cross-functional teams required
Insurance general account investment experience preferred
Experience with statutory accounting, NAIC designations, RBC capital considerations, asset liability management (ALM), private credit, structured products, commercial mortgage loans, alternatives, or limited partnerships preferred
Experience presenting portfolio assessments and investment recommendations to leadership or governance forums preferred
Strong understanding of fixed income markets, corporate credit analysis, portfolio risk oversight, and insurance investment considerations
Strong quantitative and qualitative analytical skills, including ability to synthesize large amounts of investment data into actionable recommendations

Job Responsibility

Oversee and manage outsourced investment mandates for Sammons Financial Group Asset Management (SFGAM), in partnership with SFGAM leadership
Lead day-to-day oversight of third-party asset managers across assigned mandates, including proactive manager dialogue, performance evaluation, portfolio risk assessment, and escalation of material risks
Partner with internal stakeholders and external managers to help ensure portfolios are managed consistent with investment objectives, liability considerations, regulatory expectations, capital efficiency targets, and enterprise risk tolerances
Utilize a strong understanding of fixed income markets, corporate credit analysis, insurance investment considerations, and manager-of-managers governance to support disciplined portfolio oversight and investment decision-making
Oversee third-party asset managers for assigned mandates, including recurring communication, performance evaluation, guideline monitoring, and assessment of manager capabilities, portfolio positioning, and credit risk exposures
Evaluate aggregate exposures across managers, entities, portfolios, and asset classes, including sector, issuer, rating, duration, liquidity, spread, structured credit, private asset, and concentration risks
Lead manager due diligence, benchmark-relative performance analysis, watch-list monitoring, and escalation of performance, organizational, operational, or risk management concerns
Partner with SFGAM leadership on portfolio recommendations, allocation adjustments, guideline modifications, new money deployment, and remediation actions for assigned mandates
Incorporate insurance investment considerations, including National Association of Insurance Commissioners (NAIC) designations, statutory accounting, Risk Based Capital (RBC) capital treatment, liquidity needs, and liability-aware portfolio construction, into portfolio analysis and recommendations
Prepare and present manager reviews, portfolio risk assessments, performance attribution, and investment recommendations to investment leadership and governance forums

What we offer

Comprehensive health coverage for you and your family, including Medical, Dental, Vision, HSA & FSA options, and term life insurance
Competitive compensation with a performance-based incentive program tied to clear goals and individual and/or company success
Invest in your future with our 100% company-funded Employee Stock Ownership Plan (ESOP), plus automatic enrollment in our 401(k)
Work–life balance that means something. Friday afternoons off year-round, generous paid time off, and paid holidays
Commit to your growth with paid development time, tuition reimbursement, and professional development opportunities across industry, individual, and leadership programs
Make an impact beyond the workplace through volunteer time off, and our company nonprofit matching gift program, supporting the causes that matter most to you
An ownership culture that inspires
join a connected, values-driven workplace where employees take accountability, support one another, and are empowered to do their best work—together shaping our future shared success

Fulltime

Sr. Compliance Quality Engineer

This is where you make a difference in our patients’ safety. As a member of the ...

Location

Costa Rica , Cartago

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Minimum of 4 years of experience in manufacturing processes, quality systems, regulatory compliance, and GMPs within Baxter or in companies producing healthcare devices
Validated knowledge of ISO 9001, ISO 13485, PMD Law, CMDR, MDSAP, CFR 21 and the Manufacturing Maturity Program (CMMI)
Validated experience in auditing systems and certification as an Internal Auditor
Knowledge and experience in Sterility Assurance
University training in Engineering (Production, Industrial, Chemical, Systems, Electrical, Electronics, Electromechanics) or related career
Equivalent experience in production environments with Quality Systems in the medical device manufacturing industry

Job Responsibility

Own the Complaints, CAPA, Risk Management, Hold and Corrective Actions systems, as well as their critical metrics and participation in local, regional and corporate forums
Implement the Internal Audit Program and follow up on corrective and preventive actions
Assess the regulatory alignment of processes and systems
Ensure they follow applicable directives and standards
Coordinate the system for change oversight, making sure changes stay in sync with regulatory requirements
Ensure evaluations of complaint samples, manufacturing investigations, and coordination with Product Surveillance within defined timeframes
Facilitate root cause analysis and ensure complete documentation in CAPA processes
Implement and maintain the risk system, assessing and controlling risks and leading residual risk
Ensure the accurate execution of the Hold process and the corrective field actions (FCA)
Maintain effective communication with productive areas and lead actions to reduce complaints

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer

Fulltime

Vice President, Global Head of Drug Safety (DS) & Pharmacovigilance (PV)

Location

Denmark , København og omegn

Salary:

Not provided

Life Science Talent

Expiration Date

Until further notice

Requirements

MD and 10+ years of experience in drug safety, pharmacovigilance, risk management, or related roles within the pharmaceutical/biotech industry
Experience as prior Head of DS & PV, with late-stage clinical development and with BLA/NDA/MAA submissions highly preferred
Strong leadership skills with a proven record of building and managing safety teams, including operational and compliance functions
Expertise in global PV regulations, safety surveillance, and risk management strategies
Experience with regulatory authority interactions and safety signal management
Effective communicator with excellent written, verbal, and presentation skills
Proactive self-starter with the ability to thrive in a fast-paced, high-growth environment, balancing multiple priorities while maintaining a strong commitment to ethical standards
Negotiation, influence, and strong project management and interpersonal communication skills that facilitate collaboration across functions and with consultants and CMOs

Job Responsibility

Lead and oversee Hemab DS & PV as well as risk management activities for all programs
Strategically lead the development of Hemab’s DS & PV department, including operations, compliance and medical functions, based on industry best practices
Mentor and develop a high-performing DS & PV team, fostering a culture of safety, compliance, and operational excellence
Participate as a core member of Hemab’s senior leadership team, contributing to overall company strategy
Develop and manage DS & PV budgets, ensuring alignment with corporate objectives
Collaborate cross-functionally with Clinical, Medical Affairs, Regulatory, Quality, Biometrics and other teams to drive safety initiatives
Ensure compliance with global pharmacovigilance regulations (FDA, EMA, ICH, EU GVP, and other relevant agencies)
Manage and oversee internal and external PV resources, including safety functional service providers and consultants
Develop processes for and provide safety medical oversight of safety surveillance and benefit risk assessments, including medical review of ICSRs, signal management activities, safety analyses, benefit risk profile development and monitoring, and risk mitigation strategies
Ensure that aggregate data safety signals are identified promptly and communicated appropriately, including oversight of use of signal detection tools and other sources of product signals

Fulltime

Network Administrator

The Network Administrator will play a critical role in maintaining the stability...

Location

United States , Los Angeles

Salary:

110000.00 - 120000.00 USD / Year

Robert Half

Expiration Date

Until further notice

Requirements

5+ years of experience in network administration, IT support, or similar technical role
Hands-on experience with network infrastructure (routers, switches, firewalls, VLANs, wireless)
Familiarity with enterprise networking hardware and security systems
Experience with MDM platforms such as Jamf or Microsoft Intune
Proficiency in administering collaboration and productivity platforms (e.g., Google Workspace, Slack)
Working knowledge of IT security principles, user access management, and PCI compliance basics
Experience with ticketing systems and IT asset management tools
Background supporting retail environments or point-of-sale systems

Job Responsibility

Configure, maintain, and troubleshoot network infrastructure including routers, switches, firewalls, VLANs, and wireless systems
Monitor network performance, uptime, and security
diagnose and resolve connectivity issues
Administer and support enterprise networking hardware and surveillance systems across multiple locations
Ensure reliable connectivity for point-of-sale systems and in-store technologies
Support new site build-outs, including networking, AV systems, and vendor coordination
Provide end-user support including hardware setup, troubleshooting, and ticket resolution
Manage and triage IT support requests across corporate and retail environments
Administer user access, onboarding/offboarding processes, and system permissions
Maintain IT asset inventory, ticketing systems, and documentation

What we offer

Comprehensive medical, dental, and vision benefits
Competitive overall benefits package

Fulltime

Qa/qc Inspector (Welding)

Location

China , Qingdao

Salary:

Not provided

Airswift Sweden

Expiration Date

Until further notice

Requirements

Minimum Higher National Diploma (HND) or Diploma in Mechanical, Welding, Metallurgy, or equivalent
Certification as AWS SCWI, CSWIP 3.2 Senior Welding Inspector, or equivalent
ASNT Level II certification in NDT methods (VT, MT, PT, RT, UT)
Strong knowledge of international codes and standards including AWS, API, ASME, ASNT, EN, DEP, and ISO
Proficient in MS Office and database management systems
Minimum 10 years of welding and NDT inspection experience, including at least 5 years post-certification within the Oil & Gas industry
Minimum 5 years of offshore project experience
Proven experience in inspection and testing for major oil & gas projects, including offshore process platforms and jackets across all phases (manufacturing, fabrication, construction, and installation)
Experience in inspection of structures, piping, offshore pipelines, and materials across various welding processes
Familiarity with advanced NDT techniques such as UT, AUT, and PAUT

Job Responsibility

Ensure quality requirements for fabrication, construction, and installation activities are implemented in accordance with approved quality procedures, plans, and project documentation
Verify that contractors, subcontractors, and vendors deploy competent resources, follow internationally accepted practices, and deliver products compliant with corporate and project quality standards
Participate in inspection, surveillance, and audit activities involving contractors, subcontractors, vendors, manufacturers, suppliers, and third-party inspection and certification bodies
Review and verify project quality documentation, including Inspection & Test Plans (ITPs), Method Statements, Work Procedures, and WPS/PQR documents
Confirm personnel qualifications and ensure calibration status of inspection equipment is valid
Attend material receiving inspections and review Material Test Certificates (MTCs)
Monitor welding activities at site and fabrication yards to ensure compliance with approved Welding Procedure Specifications (WPS)
Attend Procedure Qualification Record (PQR) mechanical testing and witness welder qualification tests, including evaluation of visual inspections and NDT results
Witness and interpret daily NDT activities at site and fabrication yards, and assess inspection findings
Participate in dimensional control inspections, including laser survey inspections where applicable

Fulltime

Program Manager

Amentum is seeking a Program Manager to manage a multi-million dollar prime cont...

Location

United States , Dahlgren

Salary:

135000.00 - 155000.00 USD / Year

Amentum

Expiration Date

Until further notice

Requirements

Bachelor's degree from an accredited college or university in an engineering, scientific, business, or technical discipline
Twelve (12) years of experience as a manager of a team of skilled professional, technical, and support personnel involved in Navy or Marine Corps systems design, test and evaluation, oversight and management using analysis, and quality assurance
Five (5) years of experience in Mechanical Engineering, Electrical Engineering, Physics, Mathematics, or Naval Architecture
Five (5) years of experience in Test and Evaluation related to configuration management of Command, Control, Communication, Computers, Combat Systems, and Intelligence-Surveillance and Reconnaissance (C5ISR) systems
Demonstrated experience in coordinating the management of work performed on DoD contracts containing multiple diverse work areas while managing the execution of multiple concurrent Technical Instructions
Demonstrated experience with Earned Value Management
Demonstrated ability to interface effectively with customers and to deliver quality products on time and within budget
Demonstrated ability to plan, design, coordinate, control the progress of project work to meet sponsor objectives and manage a diverse technical workforce and team consisting of multiple skill sets
Must be a U.S. citizen
Must have an active Top Secret security clearance

Job Responsibility

Manages the program to ensure fulfillment of contractual obligations including cost, quality and schedules while maintaining company profit motives
Acts as a point-of-contact for all matters relating to the assigned contract for representative between government personnel and program
Coordinates and/or approves local operating and personnel actions, policies, and procedures within the generalized framework of overall corporate guidelines
Responsible for contract administrative functions including safety, security, and labor reporting
Ensures adherence to established standards of individual performances and site discipline
Manages monetary resources in such a manner to keep the contract within budget guidelines and meet all budget objectives
Provides a high degree of customer satisfaction by quality performance and best return for their investment
Maintains as a liaison with customer representatives
Provides management guidance and control for the efficient utilization of human resources assignment, performance, morale, and overall welfare
Performs other duties as assigned

What we offer

Health, dental, and vision insurance
Paid time off and holidays
Retirement benefits (including 401(k) matching)
Educational reimbursement
Parental leave
Employee stock purchase plan
Tax-saving options
Disability and life insurance
Pet insurance

Fulltime

Executive Director, Site Head, Amgen Genome Valley (AGV)

This role is responsible for driving top performance in Site Operations at Amgen...

Location

India , Hyderabad

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Advanced degree (Ph.D or Master's degree) in Life sciences/pharmacy/similar discipline or medical degree is preferred
15+ years of experience in the pharmaceutical/healthcare industry
Excellent quantitative and qualitative skills including financial analysis
Good business acumen, high-level strategic thinking and analytical skills
Demonstrated understanding of drug discovery, commercialization, operations planning, strategic planning, commercial operations, and finance
Ability to communicate and collaborate cross functionally
Excellent conceptual problem solving/strategy skills with demonstrated ability to bring structure to vaguely defined problems
Outstanding executive verbal and written communication and presentation skills
Excellent interpersonal and influencing skills with a demonstrated ability to drive decisions
Proven experience as a member and leader of a high performing team, leadership skills, organizational and project management experience

Job Responsibility

Drive the development and execution of AGV's strategy, goals and objectives
Lead the AGV site leadership team (SLT), managing site-wide processes and providing executive guidance to support decision-making through SLT meetings and extended leadership forums
Liaise with global VP heads of the AGV staff to ensure alignment and consistency between AGV and other sites
Generate and leverage business intelligence to inform site priorities and decisions
Support business performance and strategic initiatives critical to AGV's future success
Lead and implement organizational and change management strategies to enable the organization to adapt to evolving business challenges
Develop solutions to complex business challenges through in-depth analysis, coordination and negotiation with key decision makers
Serves as primary collaborator with executive sponsors, providing executive guidance to senior management
Enable cohesive development of site strategy, priorities and initiatives, aligned with Amgen R&D's enterprise deliverables
Develop approaches to improve site productivity and efficiency

Fulltime

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Manager, Product Management - Corporate Surveillance

Job Description

Job Responsibility

Requirements

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What we offer

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