Pv Director Job at Randstad (Shanghai)

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Director Strategy and Project Management

Pearle Vision is seeking a dynamic and results-driven Director, Strategy and Pro...

Location

United States , Manhattan

Salary:

Not provided

OPSM

Expiration Date

Until further notice

Requirements

Bachelor’s degree (or equivalent experience)
10+ years of Project management, Analytics or Strategy experience in consulting, medical field or retail
Solution oriented mindset with ability to think critically, challenge the status quo, understand root causes and develop strategic frameworks
Proficient at analyzing large quantities of data
Strong interpersonal and communication skills
Fast learner who is proactive and curious by nature
Experience in running multiple complex cross-functional projects independently and simultaneously
Effectively navigates the organization, leveraging credibility to influence
Strong work ethic
Comfortable in fast paced, high stress environments

Job Responsibility

Leads the planning, execution and delivery of high-impact projects within the Strategy function, ensuring alignment with strategic objectives
Manages project timelines, milestones, budgets and deliverables with a clear focus on driving outcomes
Collaborates cross functionally with Marketing, Finance, Franchise and corporate operations and Center of Excellence Eyecare teams to ensure integration and successful execution
Serves as the subject matter expert for insurance business models within the retail optical industry in the US & Canada, identifies key trends and legal landscape evolutions
Understands the optical doctor’s revenue model, key processes & systems and growth strategies
Supports the creation of an annual PV strategy and of executive level updates for all initiatives
Build and maintain financial models to evaluate initiative impact, ROI, and resource needs
Develops in-depth analysis around business performance: exam KPIs, profitability of the different doctor set-up (employed, sub-lease, tele-optometry, medtech and audiology), correlation with relevant sales KPIs (guest count, conversion, patient experience)
Managing, leading, & tracking key priorities cross-functionally
Collaborates with cross functional partners to analyze brand performance across all strategy pillars

What we offer

Pay Range: 62,353.00 -
Benefits may include health care, retirement savings, paid time off/vacation, and various employee discounts

Fulltime

Associate Director / Director, Clinical Quality Assurance

Location

United States , Cambridge

Salary:

185000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

University degree in a scientific discipline/life sciences OR equivalent experience in biotech/pharmaceutical industry
Experience in a clinical stage biotech company preferred
10+ years of relevant experience in clinical/GCP quality
Outstanding expertise in GCP R3 and solid understanding of PV regulations
Demonstrated ability to successfully partner cross-functionally
Excellent interpersonal effectiveness, including exceptional communication skills
Advanced computer skills, including experience working in Veeva
Consistent excellent judgement and pragmatic, risk-based decision making skills
Direct experience supporting FDA and other global healthy authority (e.g., EMA, MHRA) inspections and related inspection preparation activities

Job Responsibility

Lead development and execution of enterprise-wide GCP inspection readiness strategies and plans
Conduct inspection risk assessments and coordinate mock inspections, readiness reviews, and remediation activities
Support health authority inspections, including document review, response coordination, and follow-up remediation activities
Serve as the Clinical QA Lead for assigned studies and programs
Provide quality review of protocols, informed consent forms, investigator brochures, CSRs, and regulatory submission documents
Develop and execute program/study-level risk-based audit plan, including investigator site, vendor and internal process audits
Provide quality oversight of CRO and key service providers through qualification, ongoing monitoring, and issue escalation
Provide QA oversight of TMF quality and completeness in collaboration with study teams and TMF group
Support TMF migration activities, as required
Lead quality investigations, root cause analysis, and CAPA development

Fulltime

Director, Pharmacovigilance

This is a unique opportunity to join a growing Pharmacovigilance team. This PV e...

Location

United States , Cambridge

Salary:

210000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Degree in Pharmacy, Nursing, Epidemiology, Biosciences or equivalent degree with pharmaceutical industry background and proven competence in PV
Healthcare professional degree preferred (Nurse Practitioner, Physician Assistant, RN/BSN, Pharm D, MD, or equivalent)
10+ years’ pharmaceutical industry experience, including a minimum of 5 years’ experience in PV
Knowledge of MedDRA dictionary, clinical trial methodology, medical terminology, and general principles of clinical assessment of AEs
Demonstrated knowledge of global PV regulatory environment with working knowledge of international regulations including but not limited to FDA, EU, GVP, ICH guidelines and regulations pertaining to clinical development and post-marketing safety environments
Working knowledge of industry standard safety databases (ARGUS and ARISg) and other electronic data capture systems
Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data
Experience in the preparation and authoring of pre- and post- aggregate safety reports
Thorough understanding of the drug development process and context applicable to safety surveillance activities
Ability to execute and follow-through to completion and documentation

Job Responsibility

Oversight of day-to-day safety monitoring activities and safety operations of clinical trials for assigned product(s)
Provide PV subject matter expertise on clinical development teams and other cross-functional forums throughout the company
Ensure that safety reports for assigned products are triaged, processed and submitted/distributed as required per global requirements and applicable SOPs
Perform individual case safety report assessments for clinical trial safety reports, including review of Analysis of Similar Events, as applicable
Contribute to the development and review of clinical, regulatory, and scientific documents including clinical study protocols, informed consent forms, study plans, clinical study reports, manuscripts/journal articles, scientific abstracts/posters, case report forms, statistical analysis plans, and/or other documents as needed
Facilitate internal cross-functional Safety Management Committee and/or other safety governance/review meetings
including coordinating materials, data outputs and presentation, agenda and minutes
Work closely with the Medical/Safety Lead to support signal detection activities, which may include: preparing signal assessment, tracking, and validation documents
leading cross functional teams to assess safety signals
preparing action and communication plans to mitigate/manage product risks

Fulltime

Senior Director, R&D GxP Audit

The Senior Director, R&D GxP Audit will lead the global strategy, execution, and...

Location

United States

Salary:

199782.30 - 270293.70 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 5 years of experience in Quality Assurance or Strategy in a regulated industry OR Master's degree and 9 years of experience in Quality Assurance or Strategy in a regulated industry OR Bachelor's degree and 11 years of experience in Quality Assurance or Strategy in a regulated industry
at least 5 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources

Job Responsibility

Develop and execute a global, risk-based GxP audit strategy aligned to quality and portfolio priorities
Lead internal, external, and supplier audit programs across R&D and supporting functions
Serve as a strategic advisor to the Head of R&D Quality on compliance trends, systemic risks, and assurance strategies
Build and lead a high-performing audit organization with strong technical and leadership capability
Oversee audits of clinical trial processes, pharmacovigilance systems, laboratories, quality systems, and supporting functions
Ensure audits assess both compliance to regulations and effectiveness of quality management systems
Drive consistency in audit methodology, planning, execution, reporting, and follow-up globally
Evaluate third-party quality systems, regulatory history, data integrity controls, and operational capability
Support qualification, ongoing oversight, escalation, and remediation of critical suppliers
Use quality risk management principles and data analytics to prioritize audits based on business criticality, compliance history, inspection outcomes, and emerging risks

What we offer

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible

Fulltime

Medical Director/Sr Medical Director - Neurology

Join Us as a Medical Director – Make an Impact at the Forefront of Innovation. A...

Location

United States

Salary:

Not provided

myGwork - LGBTQ+ Business Community

Expiration Date

Until further notice

Requirements

MD or equivalent required
Active medical licensure preferred
Clinical experience in treating patients in the specialty or sub-specialty associated with the applicants training (comparable to 2 years), i.e. Neurology Residency/Fellowship
Suitable clinical trial experience in a Contract Research Organization, pharmaceutical company or as a principal investigator (comparable to 1-2 years) in the industry
Direct experience in safety/Pharmacovigilance (comparable to 2 years)
Therapeutic expertise across one or more medical specialty or sub-specialties
Strong decision-making, problem solving, organizational skills and analytical skills
Excellent oral and written communication skills
Working knowledge of relevant safety databases (e.g. Medra)
Flexibility to travel domestically and internationally

Job Responsibility

Manage all medical aspects of contracted tasks across the pharmaceutical product life-cycle
Ensure tasks delegated to PV are properly executed
Adhere to applicable regulations and ICH guidelines regarding clinical trials, regulatory documents, and safety issues
Follow client SOPs/directives and project-specific WPDs for assigned projects
Comply with CRG’s corporate policies and SOPs/WPDs
Provide medical consultation to team members and answer all study-related medical questions
Communicate clearly with associates and clients, maintaining an open line of communication to ensure all procedures are followed appropriately
Provide therapeutic training and protocol training on assigned studies, as requested
Assist in writing (interpretation of safety and efficacy data) and/or reviewing CSR, IND/NDA reports, ICSR, signal detection reports, periodic reports, RMP, REMS, CTD modules, etc., to ensure that the medical content is accurate and complete
Monitor all safety variables (AE, laboratory abnormalities, changes in patient medical status, evaluation of prescribed concomitant medication for protocol restrictions, and un-blinding requests) of clinical studies

Fulltime

Director, Clinical and Safety Quality

The Clinical & Safety Quality Director is responsible for establishing, leading,...

Location

United Kingdom , Mechelen

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Minimum 10–12 years of experience in pharmaceutical or biotech environments
At least 5 years in Clinical Quality Assurance and/or Pharmacovigilance Quality roles
Direct experience supporting Phase II–IV clinical development programs
Hands-on experience with regulatory inspections and health authority interactions
Experience in global or multi regional clinical development organizations is strongly preferred
Strong expertise in ICH-GCP and GVP requirements applicable to Sponsors
Demonstrated experience in clinical and/or pharmacovigilance quality oversight in a pharmaceutical company environment
Solid knowledge of outsourced clinical development models and CRO/vendor oversight
Proven ability to lead inspections, audits, and complex quality issue resolution
Strategic mindset with the ability to balance compliance, risk management, and operational agility

Job Responsibility

Define, implement, and maintain the Clinical and Safety Quality strategy aligned with global regulatory requirements (ICH-GCP, EU CTR, GVP Modules, FDA regulations)
Ensure effective oversight of Sponsor responsibilities for outsourced clinical and pharmacovigilance activities conducted by CROs, vendors, and partners
Lead the development, maintenance, and continuous improvement of Clinical and PV Quality Management Systems, including SOPs, standards, and governance processes
Plan and execute quality oversight activities, including: Clinical and PV audits (internal, vendor, affiliates, system, and study audits), Quality risk assessments, Vendor qualification and performance monitoring
Ensure inspection readiness and act as quality lead during regulatory inspections (EMA, FDA, MHRA, PMDA) related to clinical and safety activities
Oversee CAPA management, deviation handling, and root cause analysis related to clinical and safety quality issues
Provide quality input and decision support to clinical development teams, pharmacovigilance, regulatory affairs, and senior management
Promote a quality culture across clinical and safety organizations, supporting training, coaching, and awareness initiatives
Monitor regulatory intelligence and proactively adapt quality processes to evolving requirements (e.g. EU CTR, ICH E6(R3), digital trials)
Contribute to portfolio and program governance committees as quality subject matter expert

What we offer

Competitive salary
Comprehensive benefits
Extensive opportunities for professional growth and development

Executive Director, Research & Development Quality Assurance

Joining Moderna offers the unique opportunity to be part of a pioneering team th...

Location

United States , Cambridge; Bethesda

Salary:

224900.00 - 404600.00 USD / Year

Moderna

Expiration Date

Until further notice

Requirements

Bachelor's degree in a life science or related field
advanced degree preferred
15+ years of progressive experience in the biopharmaceutical industry with deep expertise in GCP, GLP, GCLP and GVP and the ability to provide expert guidance on complex quality issues occurring in clinical trials, regulatory submissions, laboratories and PV and clinical safety
10+ years' experience leading multifunctional quality organizations within the research and development sector, with proven excellence across all facets of quality management including experience developing and managing budgets and ensuring efficient allocation of resources to support both short-term initiatives and long-term organizational goals
Expertise to oversee comprehensive resource and staffing management, building high-performing teams and fostering a culture of continuous improvement and accountability
Experience in the development and execution of robust audit schedules, coordinating cross-functional efforts to ensure compliance with industry standards and regulatory requirements through proactive planning and collaboration
Demonstrated success in developing and executing global audit programs and hosting health authority inspections with a track record of positive outcomes
Extensive knowledge of FDA, EMA, MHRA, PMDA, ICH and EU PV regulations/guidelines, including ICH E2 and EU PV legislation
Extensive knowledge of FDA, EMA, MHRA, PMDA, ICH regulations, guidance and local legislation for clinical trials, including a ICH E6 (R3)
Proven ability to collaborate and influence in a fast-paced, matrixed environment

Job Responsibility

Provide enterprise governance and oversight of GCP, GVP, GLP, and GCLP compliance across Moderna's entire development portfolio
Define and execute a robust, forward-looking quality strategy in alignment with global regulatory requirements and Moderna's innovation agenda
Act as the primary Quality business partner to R&D functional leaders across Clinical, Non-Clinical, Research, and Pharmacovigilance areas
Embed risk-based quality management principles into study design, data generation, and vendor oversight practices
Serve as the Quality leader and Inspection Host during global regulatory inspections (FDA, EMA, MHRA), ensuring timely and effective resolution of findings
Drive modernization of vendor oversight and shared accountability models, elevating external partnership performance
Build and lead a high-performing, solutions-oriented R&D QA team, rooted in scientific credibility and operational excellence
Enhance Quality Culture across R&D by promoting real-time quality management, early issue detection, and continuous feedback loops
Establish and track quality metrics and leading indicators that drive meaningful risk mitigation and compliance
Own the end-to-end quality lifecycle for deviations, CAPAs, issue management, regulatory intelligence, and inspection readiness

What we offer

Best-in-class healthcare coverage, plus voluntary benefit programs
A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
Family planning benefits, including fertility, adoption, and surrogacy support
Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
Savings and investment opportunities to help you plan for the future
Location-specific perks and extras

Fulltime

Director, Pharmacovigilance

This role can be based out of our Philadelphia, PA headquarters, hybrid, or remo...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Advanced degree (MD, PharmD, PhD, or equivalent) in a relevant scientific or medical discipline preferred
Minimum of 8–10 years of pharmacovigilance/safety experience in biotech or pharmaceutical industry, including clinical-stage programs
Strong knowledge of global pharmacovigilance regulations and guidelines (FDA, EMA, ICH)
Experience supporting clinical trials, including safety monitoring, signal detection, and aggregate reporting (e.g., DSURs)
Prior experience in cell and gene therapy, immunology, or related therapeutic areas strongly preferred
Demonstrated ability to work cross-functionally and influence without authority in a matrixed environment
Proven ability to operate both strategically and hands-on in a fast-paced, resource-constrained setting
Experience working in or with early-stage or growth-stage biotech companies preferred
Excellent analytical, communication, and problem-solving skills
Strong attention to detail and commitment to quality and patient safety

Job Responsibility

Safety Strategy Oversight: Lead pharmacovigilance strategy across clinical programs, ensuring alignment with overall clinical development plans
Serve as the safety lead on study teams, providing medical and scientific input on safety data interpretation and risk management
Contribute to the development and maintenance of safety-related documents, including DSURs, IBs, protocols, and safety sections of regulatory submissions (e.g., INDs/BLAs)
Case Management Signal Detection: Oversee case processing activities, including SAE review, medical assessment, and timely reporting in compliance with global regulations
Lead signal detection, evaluation, and risk assessment activities, including aggregate data review and benefit-risk evaluation
Ensure appropriate escalation and communication of safety signals to internal stakeholders and governance committees
Regulatory Compliance Inspection Readiness: Ensure compliance with global pharmacovigilance regulations, including FDA, EMA, and ICH guidelines
Support health authority interactions related to safety and pharmacovigilance
Contribute to inspection readiness activities and support audits and inspections as needed
Cross-Functional Collaboration: Partner closely with Clinical Development, Clinical Operations, Regulatory, and Medical Affairs to ensure integrated safety oversight across programs

What we offer

Competitive benefits including health and retirement, PTO, and stock option plans

Fulltime

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Pv Director

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