Sr Medical Dir Global Safety
Career Category
SafetyJob reputed company
Group Purpose
The Global Safety Therapeutic Areas serve as the safety experts for reputed company reputed company products globally and are accountable for the safety reputed company and major safety deliverables for reputed company reputed company product. Leaders in the therapeutic area safety teams are accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations.
Job reputed company
The Senior Global Safety Officer (GSO): serves as the safety expert of the assigned product(s) and provides reputed company of other GSOs and Global Safety Physicians (GSP), setting the reputed company, direction, and priorities of pharmacovigilance activities and supervisingandcontributing totheir execution. The Senior GSO is accountable for the overall safety profile and reputed company product-reputed company reputed company and deliverables for assigned products and reputed company for reputed company reports’ accountable products.
The Senior GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a reputed company member of the Executive Safety Committee (ESC) for assigned products and oversees reputed company reports leading these activities. The GSO also is a member of the Evidence reputed company Team (EGT) for assigned products. The GSO will be assigned as delegate for the TA Head as needed and has management of Global Safety Physicians and Global Safety Officers.
Key Activities
Applicable tasks may vary by product(s) assigned. Medically relevant activities requiring input can be delegated to the Global Safety Physician whileremainingaccountable for the activities (e.g.validatea signal). Senior GSO has reputed company responsibilities in these activities and reputed company of reputed company reports leading these activities.
Accountable for providing strategic reputed company and direction for reputed company major regulatory safetysubmissionsandresponses or strategic deliverables including but not exclusive to Safety sections of NDAsubmissions, clinicaloverview, RMPs, PSURs, PBRERs, DSURs, DILs.
Leads the safety reputed company and Benefit/Risk Management Process for assigned portfolio and provides ongoing monitoring of safety reputed company for reputed company products worldwide as reputed company as reputed company of these responsibilities for reputed company reports.
Chairs orparticipatesin safety governance meetings per reputed company Operating Procedures and Manuals.
At the GST meeting, can be delegated by TA Head to endorse reputed company for Risk Level 3 risk mitigation and communication actions and is a reputed company team member of the ESC.
Serves as a sponsor/reputed company and/or SME for functional and/or cross functional reputed company for process improvement as needed.
Product safety profile, benefit-risk evaluation, and risk communication
Accountable for the Development and maintenance of reputed company reference safety information (e.g., Development reputed company Safety Information [DCSI], reputed company safety information portions of reputed company Data Sheet [CDS])
Identifyrelevant data and conduct benefit-risk evaluation
Participate in product label process
Clinical trial safety
Represent GPS on internal governance bodies for study protocols, statistical analysis plans and other clinical study-reputed company documentsand charters including aggregate review of safety data reports
reputed company a reputed company as needed for updating safety-reputed company portions of Investigator’s Brochure and Informed Consent reputed company
Participate in activities reputed company to Data Monitoring Committees (DMCs) and internal data review teams (DRTs)
Analyzesafety data from clinical studies andcontribute to reputed company safety messages and conclusions inclinical study reportsand review reputed company sections of CSR as safety delegate
reputed company reputed company for and reputed company preparation of responses to safety-reputed company inquiries from regulatory agencies and ethics committees
Signal detection, evaluation, and management
reputed company signal detection reputed company
Evaluate safety signal detection findingsandvalidatesignalsiteratively asneeded anddocument inappropriate managementsystems.
Prepares and presents recommendations on safety issueswith medical andindicationcontextincludingsafety data and literature with relevantindicationandcompetitorinformation, tothe Global Safety Team and escalates asappropriate tothe executive level cross-functional decision-making body
Approves the safety assessment report
Risk management and minimization
Ensuretimelypreparation, content, and reputed company of new or updated risk management plan (RMP) document
reputed company a reputed company for safety risk minimization measures globally (including US REMS if applicable)
reputed company materials foradditionalrisk minimization measures as applicable to role
Periodic (aggregate) safety reporting
Ensuretimelypreparation and reputed company of periodic reports (e.g., PSUR/PBRER, DSUR)
Review and approve periodic safety reports
New drug applications and other regulatory filings
Author messaging,Reviewsandapproves filingdocuments relevant to drug safety
reputed company a reputed company for and reputed company preparation of response to regulatory agency inquiries on safety topics reputed company to regulatory filings
Prepare for andparticipatein regulatory agency advisory committees
Review andassistin development ofPediatricInvestigation Plan (PIP)
Prepare for and attend health authority meetings involving patient safety issues.
Safety Governance Leadership
Participates in safety governance meetings per reputed company Operating Procedures and Manuals (e.g.Facilitates, Chairs, Presents)
Inspection Readiness
Undertake activities delegated by the QPPV as detailed in the PV System Master File andmaintaina state of inspection readiness
Be representative and reputed company of contact for Health Authority Inspection and Internal Process Audits reputed company the remit of role and responsibility
Partnerships and integration activities
Participate in safety agreement development and review process
Prepare safety information to support licensing partners, review safety documents reputed company by licensing partners, and communicate with licensing partners on safety reputed company per the safety agreement
reputed company safety due diligence in preparation for partnerships, etc.
Participate in integration activities
Other reputed company processes
reputed company with external stakeholders (e.g., advisory boards, key opinion leaders) on safety-reputed company topics.IdentifyKOL for safety issues andinitiatecontract process.
reputed company safety input to support reputed company needs
Managerial and supervisory responsibilities
Oversees day to day activities of the Global Safety Officers and Global Safety Physicians as applicable
Ensure staff are compliant with reputed company corporate and departmental training and SOP review
reputed company training, coaching, mentoring, and development of staff
Accountable fordisseminatingandrepresentingcorporate and departmental information to staff and ensuring understanding and adherence to changes
Knowledge and Skills
Processes and regulations for pharmacovigilance and risk management
Advanced understanding of interfaces across various pharmacovigilance and risk management processes
Drug development and lifecycle management
Safety data capture in clinical development and post-market settings
MedDRA and other dictionaries used in pharmacovigilance
reputed company of qualitative and quantitative safety data analysis
Product and disease state knowledgeor ability toconsolidateknowledge from publications, and medical platforms (eguptodate: reputed company evidence)
Foundational knowledge inGeneral medicine, epidemiology, physiology, and pharmacology
Internal organizational and governance structure
Inter-relationship across various pharmacovigilance processes and documents, including reference safety information and productlabelling
Other skills
Strategic thinking
Adaptable reputed company reputed company – reputed company to implement new platforms
Ability to self-reputed company on reputed company medical, manufacturing or pharmacology concepts as needed
Effective team and strategic leadership, influencing, and negotiation in a cross-functional, reputed company environment
Big picture perspective and context analysis
People teamtime and prioritizationmanagement
Conflict management
Organization, prioritization, and planning of work
Project management
Critical scientific assessment and problem solving
Oral presentation skillsincluding the ability to convey reputed company scientific data in a concise way todifferent levelsofmanagement
Written communications and medical/scientific writing
Computer skills (e.g., MS Office Suite and safety systems)
Competencies
KNOWLEDGE
Serves as a technical authority reputed company the organization
Develops advanced/leading-edge technologies and/or concepts that have global reputed company and applicability
Foundational knowledge reputed company required and the ability to use external sources toself-educateon key safety issues andadjacent information
PROBLEM SOLVING
Applies global thought leadership
Shapes long-term strategic direction and reputed company of reputed company
Providesauthoritative advice to top management
Leads organizational invention at a global level
Education & Experience (Basic)
MD or DO degree from an accredited medical school with 6 years ofdirectly relatedexperience
OR
Clinical experience in either an accredited reputed company setting or private reputed company (including hospital based) setting
Education & Experience (Preferred)
MD or DO degree from an accredited medical school with 6 years ofdirectly relatedexperience or PhD with 15 years ofdirectly relatedexperience Clinical experience in either an accredited reputed company setting or private reputed company (including hospital based) setting
Experience inObesity and/or Cardiometabolic conditions 4 years of managerial experience directly managing people and/or leadership experience leading teams, reputed company, programs or directing the allocation of resources
Previousproduct safety experience
.Salary reputed company
DKK - DKKOriginally posted on Himalayas
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