Manager, Local Pharmacovigilance Job at Cunesoft (Mechelen)

Manager, Local Pharmacovigilance

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...

Location

Belgium , Mechelen

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

University degree in Life Science
Several years’ experience and profound knowledge in the field of pharmacovigilance
Expertise, experience and knowledge regarding relevant legislative and non legislative guidelines on pharmacovigilance
Leadership: Demonstrable ability in leading, mentoring, managing and motivation of staff (team leads)
Task and project management skills: Ability to train and support junior/new colleagues in daily activities
ability to lead small project with clearly defined scope
(Customer) Relationship skills: Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client's team lead level
Communication & presentation skills: Good communication skills (written and verbally)
capability to communicate issues and propose appropriate solutions to decision makers
Good presentation skills

Job Responsibility

Set up and manage the local pharmacovigilance system
Local Literature Search
Local ICSR Management
PV Intelligence Screening
Local PSMF Maintenance
Setting up local Organized Data Collection
Local PVA Management
Local adaptation and submission of PSUR / RMP
Local signal detection
Implementation of additional Risk Minimization Measures

Fulltime

Manager, Local Pharmacovigilance

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical...

Location

Belgium , Mechelen

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

University degree in Life Science
Several years’ experience and profound knowledge in the field of pharmacovigilance
Expertise, experience and knowledge regarding relevant legislative and non legislative guidelines on pharmacovigilance
Demonstrable ability in leading, mentoring, managing and motivation of staff (team leads)
Ability to train and support junior/new colleagues in daily activities
ability to lead small project with clearly defined scope
Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client's team lead level
Good communication skills (written and verbally)
capability to communicate issues and propose appropriate solutions to decision makers
Good presentation skills

Job Responsibility

Set up and manage the local pharmacovigilance system
Local Literature Search
Local ICSR Management
PV Intelligence Screening
Local PSMF Maintenance
Setting up local Organized Data Collection
Local PVA Management
Local adaptation and submission of PSUR / RMP
Local signal detection
Implementation of additional Risk Minimization Measures

Fulltime

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

Pharmacovigilance and regulatory affairs manager BeNeLux

Responsible for overseeing Regulatory affairs and Pharmacovigilance activities a...

Location

Netherlands , Utrecht

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Minimum 5-10 years of experience in regulatory affairs and pharmacovigilance within pharmaceutical company
Knowledge of local pharmaceutical legislation for Regulatory in the BeNeLux region
Knowledge of applicable laws and regulations to ensure full compliance
Knowledge of Regulatory affairs and Pharmacovigilance activities (act as primary contact for regulatory authorities and for external consultants in the regions, ensuring compliance of Product Information, API, approval of artworks for packaging materials and implementation of aRMM)
Proficiency in speaking, comprehending, reading and writing Dutch is required
Proficiency in speaking, comprehending, reading and writing English is required
Ability to think strategically & execute tactically

Job Responsibility

Act as local single point of contact for global functions in Regulatory Affairs and Pharmacovigilance for the BeNeLux
Act as the Local Safety Officer (LSO) for the Netherlands, Belgium and Luxembourg
Act as primary contact for regulatory authorities and for external consultants, ensuring compliance of Product Information, approval of artworks for packaging materials and implementation of aRMM
Responsible for creating and keep the local Regulatory affairs and Pharmacovigilance SOPs up to date
Responsible for training of BeNeLux team in local Regulatory affairs and Pharmacovigilance SOPs
Work closely together with Pharmacovigilance and regulatory affairs managers within the BNS cluster (BeNeLux Nordics and Switzerland) creating a network of knowledge and international cooperation and support
Collaborate with commercial, medical and market access to realize cross-functional objectives

What we offer

Competitive salary and benefits package
Opportunities for professional growth and development

Patient Access Liaison

The Patient Access Liaison (PAL) is a field-based patient access and reimburseme...

Location

United States , Oklahoma City

Salary:

158394.00 - 222256.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree OR Master's degree and 2 years of patient services and/or access and reimbursement experience OR Bachelor's degree and 4 years of patient services and/or access and reimbursement experience OR Associate's degree and 8 years of patient services and/or access and reimbursement experience OR High school diploma / GED and 10 years of patient services and/or access and reimbursement experience
Doctorate degree and 2 years of patient services, and/or access and reimbursement, experience OR Master's degree and 4 years of patient services, and/or access and reimbursement, experience OR Bachelor's degree and 6 years of patient services, and/or access and reimbursement, experience

Job Responsibility

Serve as a resource on patient access and reimbursement for infused and specialty therapies
Assist patients, caregivers, and healthcare providers in navigating insurance benefits, prior authorization requirements, and reimbursement processes
Support the identification and resolution of access challenges, including coverage questions, prior authorization barriers, and denied claims
Provide education regarding coding and billing considerations relevant to therapy access
Develop relationships with patients and caregivers through phone, virtual, and in-person engagement
Secure written or electronic patient HIPAA authorization within assigned geography
Assess individual patient needs and provide education and resources that support access to therapy
Educate patients on coverage considerations and the steps required to obtain prior authorization
Provide information regarding co-pay assistance programs, national foundations, and free drug programs when appropriate
Educate physician offices and sites of care on therapy coverage pathways and reimbursement processes

What we offer

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 and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Patient Access Liaison

The Patient Access Liaison (PAL) is a field-based patient access and reimburseme...

Location

United States , Charlotte

Salary:

158394.00 - 222256.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
OR Master's degree and 2 years of patient services and/or access and reimbursement experience
OR Bachelor's degree and 4 years of patient services and/or access and reimbursement experience
OR Associate's degree and 8 years of patient services and/or access and reimbursement experience
OR High school diploma / GED and 10 years of patient services and/or access and reimbursement experience
For Level 6: Doctorate degree and 2 years of patient services, and/or access and reimbursement, experience
OR Master's degree and 4 years of patient services, and/or access and reimbursement, experience
OR Bachelor's degree and 6 years of patient services, and/or access and reimbursement, experience

Job Responsibility

Serve as a resource on patient access and reimbursement for infused and specialty therapies
Assist patients, caregivers, and healthcare providers in navigating insurance benefits, prior authorization requirements, and reimbursement processes
Support the identification and resolution of access challenges, including coverage questions, prior authorization barriers, and denied claims
Provide education regarding coding and billing considerations relevant to therapy access
Develop relationships with patients and caregivers through phone, virtual, and in-person engagement
Secure written or electronic patient HIPAA authorization within assigned geography
Assess individual patient needs and provide education and resources that support access to therapy
Educate patients on coverage considerations and the steps required to obtain prior authorization
Provide information regarding co-pay assistance programs, national foundations, and free drug programs when appropriate
Educate physician offices and sites of care on therapy coverage pathways and reimbursement processes

What we offer

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 and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Patient Access Liaison

Join Amgen’s Mission of Serving Patients. At Amgen, if you feel like you’re part...

Location

United States , Houston

Salary:

158394.00 - 222256.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree
Master's degree and 2 years of patient services and/or access and reimbursement experience
Bachelor's degree and 4 years of patient services and/or access and reimbursement experience
Associate's degree and 8 years of patient services and/or access and reimbursement experience
High school diploma / GED and 10 years of patient services and/or access and reimbursement experience
Doctorate degree and 2 years of patient services, and/or access and reimbursement, experience
Master's degree and 4 years of patient services, and/or access and reimbursement, experience
Bachelor's degree and 6 years of patient services, and/or access and reimbursement, experience

Job Responsibility

Serve as a resource on patient access and reimbursement for infused and specialty therapies
Assist patients, caregivers, and healthcare providers in navigating insurance benefits, prior authorization requirements, and reimbursement processes
Support the identification and resolution of access challenges, including coverage questions, prior authorization barriers, and denied claims
Provide education regarding coding and billing considerations relevant to therapy access
Develop relationships with patients and caregivers through phone, virtual, and in-person engagement
Secure written or electronic patient HIPAA authorization within assigned geography
Assess individual patient needs and provide education and resources that support access to therapy
Educate patients on coverage considerations and the steps required to obtain prior authorization
Provide information regarding co-pay assistance programs, national foundations, and free drug programs when appropriate
Educate physician offices and sites of care on therapy coverage pathways and reimbursement processes

What we offer

Health and welfare plans for staff and eligible dependents
Financial plans with opportunities to save towards retirement or other goals
Work/life balance
Career development opportunities
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
Discretionary annual bonus program or for field sales representatives a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models including remote work arrangements where possible

Fulltime

Qpi Expert – Audit Management Lead

We are looking for an experienced QPI Expert – Audit Management Lead to drive au...

Location

France

Salary:

Not provided

Product Life Group

Expiration Date

Until further notice

Requirements

8+ years of experience in Quality within the pharmaceutical industry
Strong exposure to Pharmacovigilance (PV)
Qualified GVP Auditor with solid QMS expertise
Good understanding of regulatory frameworks (ICH, GCP, ISO standards)
Fluent in English
French (preferred)
Strong stakeholder management and client-facing skills

Job Responsibility

Define and implement the annual internal and vendor audit strategy
Lead internal, vendor, and client audits
manage findings and CAPAs
Act as key contact for client auditors and health authority inspections
Develop, maintain, and continuously improve the QMS (including ISO 9001 alignment)
Oversee SOPs, controlled documentation, and quality tracking systems
Drive process improvements and ensure compliance with ICH, GCP, GVP, and local regulations
Manage vendor quality oversight and risk-based audit programs
Lead and mentor a small team (1–3 members) and collaborate cross-functionally

Fulltime

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Manager, Local Pharmacovigilance

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Manager, Local Pharmacovigilance

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Qpi Expert – Audit Management Lead

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