Senior Manager Pharmacovigilance Job at iconplc (Mexico City)

Senior Manager Pharmacovigilance

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

Brazil , Sao Paulo

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Degree in life sciences, pharmacy, or a related field
Significant experience in pharmacovigilance or drug safety, ideally within the clinical research or pharmaceutical industries
High level of English proficiency
Based on Brazil
Strong understanding of regulatory requirements related to drug safety and reporting
Excellent analytical and problem-solving skills, with a focus on data-driven decision-making
Strong communication and interpersonal skills, capable of engaging and influencing diverse stakeholders

Job Responsibility

Managing the pharmacovigilance team to ensure timely and accurate reporting of adverse events and safety data in compliance with regulatory standards
Developing and implementing pharmacovigilance policies and procedures to enhance safety monitoring and risk management practices
Collaborating with cross-functional teams, including clinical operations and regulatory affairs, to ensure integration of safety data into clinical development plans
Monitoring and analyzing safety data trends to identify potential risks and inform decision-making for ongoing clinical trials
Staying updated on industry regulations and best practices in pharmacovigilance to drive continuous improvement initiatives

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Regional Pharmacovigilance Senior Manager

ICON plc is a world-leading healthcare intelligence and clinical research organi...

Location

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Master’s degree in pharmacy, nursing, healthcare or other life-science or technical field (PharmD or MD is a plus)
At least 7-12 years of experience in the pharmaceutical/biotech industry or at the regulatory authorities with at least 5 years in pharmacovigilance/drug safety
Working knowledge of pharmacovigilance regulatory requirements and GVP guidance documents
Knowledge of the drug development process, GXP quality and compliance requirements
Good presentation skills with the ability to communicate complex issues clearly
Good planning and organizational skills with ability to manage competing priorities
Good oral and written communication skills
Ability to motivate, influence, and collaborate with multidisciplinary teams
Ability to work independently and in a global environment and have experience of this
Understanding of safety business processes and systems for the collections of adverse events

Job Responsibility

Serve as scientific expert and pharmacovigilance resource to external and internal partners within the region
Assess current processes to ensure adherence to applicable regulatory requirements and, where needed, enhance and/or develop new processes while assuring consistency with client standards
Support the Head of Regional PV and EU/UK QPPV and the Regional PV Leads in the harmonization of processes across the regions
Liaise between the global functions, the affiliates and Business Partners (overall Territories: EU, Canada, Australia, US, Japan and Brazil, MENA, South Korea, China, Singapore)
Support the Head of Regional PV and EU/UK QPPV and the Regional PV Leads in the management of innovation projects for increasing Regional Team efficiency
Support the Regional PV Leads in the establishment and maintenance of the applicable pharmacovigilance system specific to the country/region
Support the Regional PV Leads in the revision of documents pertinent to Regional PV tasks
Promote increased awareness of and ensure compliance with pharmacovigilance obligations for the country/region
Contribute to the Pharmacovigilance System Master File (PSMF) data collection in any applicable country/region
Contribute to increase the visibility of the GPS team/function throughout

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Senior Product Manager, Clinical Safety and Pharmacovigilance Systems

Moderna is seeking a Senior Product Manager – Clinical Safety and Pharmacovigila...

Location

United States , Cambridge, Massachusetts; Bethesda, Maryland

Salary:

145900.00 - 234200.00 USD / Year

Moderna

Expiration Date

Until further notice

Requirements

Prior 7+ years' experience in the pharmaceutical or biotechnology industry
Strong domain expertise in Pharmacovigilance, including safety case processing, aggregate reporting, and post-marketing surveillance
Demonstrated product management experience delivering technology solutions in a life sciences or healthcare environment
Hands-on experience serving as System Owner for validated GxP systems
Solid working knowledge of GxP, GAMP5, and regulatory expectations for computerized systems supporting safety operations
Familiarity with Argus Safety, Veeva Vault and other PV ecosystem platforms and integrations
Experience working with agile software development teams in a digital product model
Ability to collaborate across time zones and cultures
strong cross-functional communication and influence skills
A mindset focused on curiosity, ownership, and continuous learning, aligned with Moderna Mindsets

Job Responsibility

Serve as System Owner for Clinical Safety and Pharmacovigilance systems, accountable for end-to-end system operations, governance, and lifecycle planning
Manage and continuously improve the release management process, including planning, testing, and deployment of new system features and enhancements
Ensure full GxP compliance and audit readiness, working in partnership with Quality, IT Compliance, and Regulatory teams
Contribute to the definition and delivery of the product strategy and roadmap in alignment with business needs
Support execution of the roadmap by coordinating initiatives across functions
Support the evaluation and implementation of innovative capabilities such as AI/ML to enhance safety operations
Collaborate with agile software squads to develop and deliver custom features and scalable solutions supporting safety operations
Contribute domain knowledge to adjacent systems and processes, including regulatory information management and quality compliance systems
Proactively challenge existing solutions and workflows, identifying opportunities for simplification, optimization, and innovation
Operate effectively in a global, cross-timezone team environment with colleagues and partners in the U.S., Poland, and India

What we offer

Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
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
annual discretionary bonus
other incentive compensation
equity award

Fulltime

Senior Manager/ Manager – Medical Information

Maintain and oversee the Theramex Global Medical Information (MI) function, incl...

Location

United Kingdom; Poland , London; Warsaw

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Educated to degree level in life sciences or pharmacy
Significant hands-on experience in Medical Information within the pharmaceutical industry
Experience managing people and leading teams and external service providers
Ability to work in a dynamic environment with shifting priorities and manage multiple tasks with strong attention to detail
Clear and fluent communication in English
Ability to work effectively in a multinational organisation and maintain high operational standards
Experience in Women’s Health and familiarity with the ABPI Code are desirable but not essential

Job Responsibility

Line-manage the Theramex Medical Information and Customer Service teams, while also supporting external service providers involved in MI delivery
Prepare and analyse Medical Information reports, including KPIs related to system and team performance
Act as the Medical Information subject matter expert for internal and external stakeholders, including during audits and inspections
Support the MI and Customer Service teams in handling incoming enquiries
Oversee the preparation and maintenance of procedural documents related to Medical Information activities
Collaborate cross-functionally to meet business goals and support broader organisational priorities

What we offer

A fast-paced environment with broad exposure, where you can develop professionally—even outside your area of expertise
A culture that champions continuous learning, celebrates success, and recognises performance
Opportunities for driven, talented professionals who want to be part of our exciting, purpose-led journey

Parttime

Senior Manager, Patient Safety

The Senior Manager, Medical Device end to end Management is a leadership role re...

Location

India , Hyderabad

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in Patient Safety Services
demonstrated success in clinical, medical, or scientific domains
People management capabilities with experience leading teams
Experience in client relationship management
Understanding of pharmacovigilance operations, clinical research methodologies, and regulatory frameworks
Clinical experience with progressive responsibilities
Strong clinical, regulatory, and medical Patient Safety Services knowledge
Good understanding of ICH, CIOMS, GVP, and pharmacovigilance requirements
Familiarity with automation/AI in pharmacovigilance
Adaptable mindset with enthusiasm for learning

Job Responsibility

Lead the complete lifecycle of medical device complaint handling and post-market surveillance
Oversee FDA MDR reporting including 5-Day, 30-Day, and Supplemental Reports
Ensure high-quality investigations, root cause analysis, and CAPA linkage
Maintain compliance with 21 CFR 803, 820, ISO 13485, and internal QMS standards
Partner with Regulatory, Quality, R&D, and Manufacturing teams to manage product performance and patient safety insights
Support FDA inspections and internal/external audits
Manage and mentor a high-performing complaint operations team
Delegate work to Patient Safety staff according to allocated budget/hours
Coordinate with Solutions Consultant and/or regional Head of Safety Services as appropriate to assign resources to the project, and to assess staffing needs for current and future activities
Conduct interviews for recruitment of new personnel as necessary

Fulltime

Senior Pharmacovigilance Specialist

Location

Switzerland , Baar

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Strong ability to interpret, analyze, and present scientific and medical data clearly in both verbal and written formats
Expertise in pharmacovigilance processes, including safety signal management, aggregate report authoring, and regulatory compliance
Solid understanding of global clinical trial and post-marketing safety regulations
Proficiency in data processing tools such as Excel, PowerPoint, and Word, as well as familiarity with safety database systems
Demonstrated leadership and collaboration skills within cross-functional teams
Strong organizational abilities, with the capacity to prioritize tasks independently
Educational background in biological or natural sciences, health disciplines, or an advanced degree (e.g., PhD, MPH, NP, PharmD)
Experience in pharmacovigilance, particularly in aggregate safety reporting and signal management

Job Responsibility

Lead safety signal management processes, including detection, tracking, documentation, and evaluation of safety data
Synthesize data from multiple sources and author signal evaluation reports
Manage literature reviews to identify relevant safety information
Oversee the preparation, review, and finalization of aggregate safety reports, such as PSURs, DSURs, Risk Management Plans (RMPs), and other related documents
Respond to safety-related inquiries from regulatory authorities
Collaborate with cross-functional teams, including Safety, Clinical Development, Medical Affairs, and Regulatory, to support investigational programs and clinical trial activities
Provide clinical judgment and analysis for case information and safety data
Facilitate Safety Signaling Team meetings and ensure alignment on safety strategies

Fulltime

Senior Manager, Global Medical Affairs (Uterine Health)

We are seeking a highly motivated and experienced Senior Manager, Global Medical...

Location

United Kingdom , London

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Medical degree with GMC registration or equivalent international qualification or Master of Pharmacy with GPhC registration
Previous experience in Medical Affairs, Clinical Research, or Pharmacovigilance within the pharmaceutical industry
Very good understanding of Medical Affairs' role as scientific enabler and strategic partner in a pharmaceutical company
Strong knowledge and subject matter in women's health
Ability to cut through scientific complexity and to communicate precisely and clearly with different target audiences
Strong interpersonal and leadership skills and track record of expertise working in a cross-functional environment
Strong analytical and strategic thinking
Strong business acumen
Highest professional work ethics
Proven knowledge of the ABPI Code of Practice and codes of international associations of the pharmaceutical industry, with experience in reviewing and/or certifying materials.

Job Responsibility

Develop and implement medical plans aligned with business objectives and manage associated budgets
Provide expert medical input across the product lifecycle including evidence generation, evidence dissemination (e.g. health care professional education programs), and medical experts’ engagement programs (e.g. advisory boards)
Build and maintain relationships with international therapy area experts and medical-scientific professional societies
Act as a medical reviewer for promotional and non-promotional materials in line with the ABPI and international associations of the pharmaceutical industry codes as well as internal SOPs
Support regulatory and market access submissions with clinical content
Ensure compliance with all relevant regulations and contribute to continuous process improvement
Ensure operational excellence.

Fulltime

Quality Compliance Senior Manager - Labelling & Regulatory Affairs

Location

United Kingdom , Cambridge; Uxbridge

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Degree educated
Experience in Quality Management, Quality Compliance or other relevant risk-based quality practices in the pharmaceutical/biotech industry and thorough knowledge of R&D processes and operations
Thorough knowledge and application of international requirements of Good Pharmacovigilance Practice (GPvP) & Regulatory Affairs
Previous experience supporting regulatory authority inspections of pharmacovigilance activities
Experience of leading and/or supporting process improvement initiatives
Previous leadership or mentoring experience is ideal

Job Responsibility

Act as the Quality Lead contact for Labelling & Regulatory Affairs activities within R&D Quality
Ensure proactive identification of issues relating to processes, programs, and external relationships, escalate issues to appropriate compliance/quality oversight bodies and participate in compliance investigations, management, and remediation
Assess and manage risks including providing input into the development of the annual GPvP audit plan
Participate as the Quality representative for evaluating and providing oversight of Labelling and Regulatory Affairs vendors/service providers
Prepare, analyze, and communicate compliance metrics (e.g., deviation, audit and inspection data) and other significant compliance information
Represent R&D Quality during governance and management review meetings that involve Labelling and Regulatory Affairs
Maintain knowledge of current regulatory and compliance practices/issues, assess changes in regulations and the external environment, and advise customers
Support inspections and external audits, including preparing, conducting, and closing out response reviews
Provide support for audit planning meetings, debriefs, audit plan outlines and response reviews
Develop long-term remediations and process improvements through Root Cause Analysis (RCA)

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Ability to work flexibly from home with occasional office work

Fulltime

Select Country

Senior Manager Pharmacovigilance

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

Looking for more opportunities?

Senior Manager Pharmacovigilance

Senior Manager Pharmacovigilance

Regional Pharmacovigilance Senior Manager

Senior Product Manager, Clinical Safety and Pharmacovigilance Systems

Senior Manager/ Manager – Medical Information

Senior Manager, Patient Safety

Senior Pharmacovigilance Specialist

Senior Manager, Global Medical Affairs (Uterine Health)

Quality Compliance Senior Manager - Labelling & Regulatory Affairs

Our AI answers in your language