Associate Director, Global CST, Pharmacovigilance PSMF and Business Process Management
$166.5k - $203.5kMadrigal Pharmaceuticals
Associate Director role managing global Pharmacovigilance System Master File (PSMF) lifecycle and optimizing business processes. Reports to Senior Director of Global Pharmacovigilance Compliance and collaborates across clinical, regulatory, and quality functions to ensure inspection readiness and regulatory compliance.
Responsibilities
- Manage end-to-end PSMF authoring, review, and maintenance using Veeva SafetyDocs
- Coordinate with cross-functional leaders to gather accurate pharmacovigilance data inputs
- Monitor global regulatory updates and drive proactive PSMF system changes for compliance
- Develop and optimize business processes through mapping, analysis, and re-engineering
- Compile KPIs, KRIs, and quality metrics for executive leadership and inspection readiness
Requirements
- Bachelor's degree in healthcare or scientific field
- 10+ years pharmacovigilance experience; 4+ years in PV compliance and quality
- Proven track record supporting PSMF lifecycle and business process management
- Knowledge of FDA, EU GVP, and pharmaceutical compliance requirements
- Direct experience with case processing, data quality review, and quality metrics
- Strong organizational, problem-solving, and analytical skills
- Excellent written and verbal communication abilities
Compensation: $166,500 - $203,500 per year
Vacancy posted 22 days ago
Similar jobs that could be interesting for youBased on the Associate Director, Global CST, Pharmacovigilance PSMF and Business Process Management in Conshohocken, PA vacancy
$166.5k - $203.5k
...metabolic dysfunction-associated steatohepatitis (MASH)... ...Reporting to the Senior Director, Global Pharmacovigilance Compliance, Standards... ...collaboration with business process owners (BPOs) develop... ...Pharmacovigilance System Master File (PSMF) life-cycle management. Position...SuggestedMinimum wageFull timeWork at officeLocal areaFlexible hoursMadrigal Pharmaceuticals
Conshohocken, PA2 days ago$169.22k - $201.94k
...metabolic dysfunction-associated... ...Vice President, Global Clinical Safety... ...the Associate Director, Global Clinical... ...Clinical Safety & Pharmacovigilance (CSPV)... ...safety and PV processes highly desirable... ..., experience, business needs and market... ...Pharmaceuticals’ Hiring Managers, seeking to...SuggestedMinimum wageFull timeLocal areaFlexible hoursMadrigal Pharmaceuticals
Conshohocken, PA3 days ago$129k - $203.1k
...DescriptionPosition Description:Investigator - Global Security Insider Risk Trade... ....Responsibilities:Manage/assist with complex Insider... ...in collaboration with business partners (i.e., IT Risk Management... ...can engage in a hiring process that exhibits their true capabilities...SuggestedFull timeFor contractorsWork at officeLocal areaMerck Sharp & Dohme (MSD)
West Point, PA3 days ago- ...proprietary assets and platforms, deep process and industry expertise, and... ...right delivery standard. You manage and develop your team, coach... ...to explain how AI addresses business problemsSet Yourself Apart:... ...is a leading global professional services company...SuggestedFull timeLive inWork at officeLocal area
Accenture
Philadelphia, PA4 days ago - The Opportunity:As the Associate Director, Lead Counsel,... ...throughout the contracting process, ensuring alignment,... ...stakeholders, including business units, legal teams,... ...support the global leadership teams located... ...contracting experience.Risk Management and Compliance:...SuggestedFull timeContract workWork at officeFlexible hours
CSL
King of Prussia, PA3 days ago $186k - $220k
...Job Description The Associate Director, Site Engagement Lead... ..., Clinical Trial Management, Site Management, Feasibility... ...assumptions, processes, and approaches where... ...patients, and the broader business to deliver meaningful... ...experience in global clinical development....Relocation packageCSL
King of Prussia, PA6 days ago- ...to the VP, US Sales, the Associate Director, Sales Operations serves as a strategic business partner responsible for optimizing... ...strategies, performance management frameworks, business processes, and field engagement... ...BehringCSL Behring is a global biotherapeutics leader...Full time
CSL
King of Prussia, PA4 days ago - ...cost.Job Description• Flex position in Global Labeling, for a Global Labeling Product... ...packaging components through the LWG and LC processes, as required • Ensuring quality of... ...United States Package Insert (USPI) and associated patient labeling, EU Product Information...Work at officeImmediate startFlexible hours
Artech
Spring House, PA1 day ago $142.4k - $224.1k
...Global Commercial & Launch Excellence | Immunology... ...Opportunity The Associate Director, US Launch Excellence... ...critical path rather than managing activities in... ...working across people, process and technology, including... ...Bachelor's degree in Business, Marketing, General...For contractorsLocal area$129k - $203.1k
...responsible for representing Global Regulatory Affairs... ...Safety (GRACS) on business development... ..., this position will manage the GRACS activities... ...impacted functions/ processes; responsibility will... ..., People Management, Pharmacovigilance, Policy Implementation...Contract workFor contractorsLocal areaFlexible hours$198k - $357k
...KPMG is currently seeking an Associate Managing Director to join our Enterprise... ...management teams to implement business requirements and change management... ...their contracting process and technology needs, provide... ...work effectively across a global networkApplicants must be authorized...Contract workH1bLocal areaKPMG
Philadelphia, PA5 days ago$110k - $120k
...Job Description Associate Director, Quality Assurance... ...with the organization’s global QA team to maintain harmonized... ...Leadership and Team Management Lead, develop and... ..., facility and process audits, and data and... ...coverage. Support business development and project...Contract workTemporary workLocal areaKelly Services
Malvern, PA7 days ago$156.9k - $247k
...Responsibilities Business Partnership: Provide actionable... ...insights. Project Management: Manage analytics and... ...to the business processes and strategies using data... ...Support Services and associated analytics including... ...Acts Our company is a global health care leader...For contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- Life changing therapies. Global impact. Bridge to thousands of biopharma... ...to Report (R2R) Global Process Owner is responsible for... ...R2R process across all three business units. Reporting directly to... ...user acceptance testing (UAT), managing defect resolution, and driving...Full time
PCI Pharma Services
Philadelphia, PA4 days ago $177.48k
...REQUISITIONEast Region- Business Performance... ...Strategic Sourcing Associate DirectorLOCATIONPHILADELPHIAADDITIONAL... ...Associate Director You Belong Here... ...the most trusted global consulting firm.... ...to identify and manage finance... ...Successful You enjoy process, relevant analytics...Full timeContract workTemporary workWork at officeLocal areaRemote workFlexible hoursProtiviti
Philadelphia, PA5 days ago$137k - $235.75k
...Product Safety Risk Management Job Category:... ...best talent for Associate Director, Safety Analysis... ...position across Global Medical Safety (... ...without defined processes. May seek... ...Medical writing or Pharmacovigilance (PV) experience... ...stakeholders, including business partners....Full timeFor contractorsLocal areaImmediate start$156.9k - $247k
...Job Description Associate Director, Strategic Forecasting Insights... ...these to the business to help action the marketing... ..., including Global and Regional Marketing... ...enterprise forecasting process, working closely across... ...and positively managing ambiguity. Self-motivated...Full timeFor contractorsLocal areaRelocationVisa sponsorshipFlexible hoursShift work- Job Purpose: The Associate Director, Medical Affairs is responsible for... ...into the development of global publication strategies... ...with global strategy and business priorities.Provides scientific... ...with advisory board processes, content management systems, and medical / regulatory...Full timeWork at office
CSL
King of Prussia, PA4 days ago $156k - $234k
...Pharmaceuticals is a global biopharma company whose... ...as One Jazz. The Associate Director, Commercial Global... ...data sourcing, vendor management, and data inventory management... ...commitments and business expectations ·... ...to regularly improve processes/capabilities through...Contract workLocal areaRemote workWorldwideFlexible hours- ...to support and grow a global team, own the strategy... ...direction for the people, processes, and technology to... ...Work closely with the Director, Security Operations to... ...- This role will manage a team of Forensics, eDiscovery... ...or advanced degree in business or industry-related...Full timeWork experience placementImmediate start
CSL
King of Prussia, PA4 days ago $179.36k - $205.68k
...metabolic dysfunction-associated steatohepatitis (MASH)... ...way. The Associate Director (AD) TMF Operations will... ...QC oversight, metrics management, issue escalation, and... ...will ensure that TMF processes are consistently... ...serve as the primary business owner for TMF operational...Minimum wageFull timeLocal areaFlexible hours$212k - $251k
...Position Purpose: The Associate Director (AD), Biostatistics, leads the... ...and regulatory documents. Manage outsourcing operations or work... ...of clinical development and processes Ability to... ...Behring CSL Behring is a global biotherapeutics leader driven...Interim roleLocal areaRelocation packageCSL Behring
King of Prussia, PA2 days ago$160k - $240k
...Pharmaceuticals is a global biopharma company whose... ...Operating Model to Power Our Business: At Jazz, we are... ...reports to the Senior Director of Data Enablement &... ..., HCP/HCO master data management platforms and... ...to regularly improve processes/products through reflection...Local areaRemote workWorldwideFlexible hours- ...Associate Director, Client Advisory Newtown Square, PA... ...is a growing wealth management firm serving ultra-high... ...planning coordination, business development, operational... ...quarterly reporting processes, including... ...Foundational knowledge of globally diversified investment...Work at officeFlexible hours
- ...Summary: Reporting to the Director of Strategic Forecasting &... ...HematologyThis position will manage projects and initiatives supporting... ...and answering key business questions globally, influencing R&D and clinical... ...part of the application process, please visit .SummaryLocation...Full timeTemporary workFor contractorsLocal area
CSL
King of Prussia, PA2 days ago - ...with the Lead Counsel, Global Clinical Development, as the Associate Director, Senior Counsel, Clinical... ...that are not otherwise managed by CRO, procurement, or... ....Provide strong business partnering support for... ...part of the application process, please visit .SummaryLocation...Full timePrivate practiceWork at office
CSL
King of Prussia, PA5 days ago - ...DescriptionAt IPS, we are global leaders in developing innovative... ...procurement, construction management, and CQV of technically... ...industry. We are looking for a Director of Process Controls to lead our US... ...the development of strategic business plans in concert with...Work at office
Integrated Project Services
Blue Bell, PA3 days ago - The Opportunity The Associate Director, Incentive Compensation... ..., and aligned to business objectives. This position... ...strategies while managing the details required... ...incentive compensation processes. This is a hybrid role... ...Behring CSL Behring is a global biotherapeutics...Remote work
- ...accommodation or an alternative application process. Associate Director, Physical/Chemical Charact Full Time... ...to redefine the landscape of the global genetic medicines industry. As a... ...technical expert and will be responsible for managing the quality control processes for...Full timeContract workTemporary workRemote workFlexible hoursNight shiftWeekend workAfternoon shift
- The Associate Director, Procurement Enablement of Responsible... ...Procurement & Supplier Management (ESPM). Reporting to... ...adoption of new processes, tools, and ways of working... ...pathways aligned to business and procurement... ...results in a complex, global environment.Balance strategic...Full time
CSL
King of Prussia, PA3 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Associate Director, Global CST, Pharmacovigilance PSMF and Business Process Management. Be the first to apply!
Related searches
- associate manager Conshohocken, PA
- associate director Conshohocken, PA
- drug safety specialist Conshohocken, PA
- drug safety associate Conshohocken, PA
- drug safety physician Conshohocken, PA
- pharmacovigilance manager Conshohocken, PA
- abbvie associate director
- freelance associate creative director
- associate director contracts
- associate general manager