Pharmacovigilance Associate I Job at Cencora (Remote)

Patient Safety Associate I (Drug Safety Associate I)

At Parexel, we’re dedicated to improving patient health worldwide. As a Patient ...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Foundational knowledge of drug safety regulations and pharmacovigilance processes
Ideal candidate has 3+ years experience in Drug Safety
2+ years experience in a post marketing
Experience in multiple therapeutic areas (cardiology, neurology, oncology, rare disease)
Strong attention to detail, organizational skills, and problem-solving ability
Effective communication and willingness to work in a collaborative team environment
Proficiency with MS Office and ability to learn safety systems/databases
Preference for those with Veeva Safety experience
Bachelor’s degree in Life Sciences, Health Sciences, Biomedical Sciences (e.g., Pharmacy, Microbiology, Biochemistry, Biotechnology) or equivalent education/experience

Job Responsibility

Processing Individual Case Safety Reports (ICSRs) from multiple sources with accuracy and efficiency
Conducting comprehensive literature searches and reviews to identify safety signals
Supporting signal detection and management activities
Tracking and monitoring regulatory information updates
Assisting in preparing and executing regulatory submissions
Contributing to the development of aggregate reports and study-specific safety documents
Managing Medical and Product Dictionary activities where applicable
Maintaining compliance through quality reviews of safety deliverables
Generating metrics and performance indicators for safety operations
Investigating and documenting late deliverable incidents

Graduate Pharmacovigilance Associate

As a Graduate Pharmacovigilance Associate at ICON, you will support the safety m...

Location

Poland , Warsaw

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor's degree in pharmacy, life sciences, or a related field
Strong attention to detail and organizational skills, with the ability to manage multiple tasks and prioritize effectively
Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment
Basic understanding of pharmacovigilance principles and regulatory guidelines is desirable but not required
relevant training will be provided
Proficiency in Microsoft Office applications, with good analytical and problem-solving skills

Job Responsibility

Supporting the collection, review, and processing of adverse event data in accordance with pharmacovigilance regulations and company procedures
Assisting in the preparation and submission of safety reports to regulatory authorities and stakeholders
Collaborating with cross-functional teams to ensure timely and accurate communication of safety information
Contributing to the development and maintenance of pharmacovigilance documentation, including standard operating procedures and safety management plans
Participating in training and development activities to gain a deeper understanding of pharmacovigilance practices and regulatory requirements

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 Associate

Our team members are at the heart of everything we do. At Cencora, we are united...

Location

Canada , Oakville

Salary:

48500.00 - 74690.00 CAD / Year

Cencora

Expiration Date

Until further notice

Requirements

Bachelor’s degree in a life sciences program
1-2 years of experience in Pharmacovigilance, Medical Information, Clinical Research, and/or equivalent and related experience in the pharmaceutical industry
Strong knowledge of the pharmacovigilance industry including up-to-date knowledge of Health Canada, US-FDA, and ICH’s Pharmacovigilance requirements and guidelines
Familiarity with MS Word, MS Excel, MS PowerPoint, other MS Office Programs, and Adobe Pro
Familiarity with Good Documentation Practice (GDP) and Quality Management Systems (QMS) is an asset
Strong business and financial acumen
Strong analytical and mathematical skills
Ability to communicate effectively both orally and in writing
Effective interpersonal and leadership skills
Effective organizational skills, attention to details

Job Responsibility

Accountable for recognizing Adverse Event (AE) / Adverse Drug Reactions (ADR) / Adverse Drug Experience (ADE), Medical Device Incident (MDI) information from the source document
Accountable for Individual Case Safety Report (ICSR) processing as per applicable Standard Operating Procedures (SOPs) and Work Instructions (WI) including but not limited to Triage, Duplicate Search, Data Entry, MedDRA coding, Narrative Writing, Medical Evaluation, Seriousness assessment, expectedness assessment, Causality assessment, Reportability Assessment, Expedite, and Periodic submission, etc.
Accountable to perform AE / ADR/ ADE / MDI reports’ reconciliation with internal and external stakeholders
Accountable to perform Literature Review as per the applicable organization’s SOP and WI
Accountable for recognizing, processing, and reporting Product Quality Complaints (PQC) information as per applicable SOP and WI
Accountable for managing Mailboxes including filing emails in appropriate folders
Accountable to review and file incoming Faxes in the appropriate folder
Accountable to act as a contact point for the client
Work directly with internal and external stakeholders to request additional information or clarification as necessary
Assist in audit preparation

What we offer

medical
dental
vision care
comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness
support for working families
backup dependent care
adoption assistance
infertility coverage
family building support
behavioral health solutions

Fulltime

Pharmacovigilance Associate

Pharmacovigilance Associate- Clinical Trial Cases/ LSMV Database skills. ICON pl...

Location

India , Chennai

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Minimum 2 years of experience in safety background, with direct involvement in case processing
Clinical Trial cases OR Hands-on LSMV database skills
Bachelor's degree in life sciences, pharmacy, or a related field
advanced degree preferred
Must have 2+ years in PV Case processing
Strong analytical skills with attention to detail in data collection and reporting
Excellent communication and interpersonal skills
A commitment to maintaining high standards of quality and compliance

Job Responsibility

Collect, assess, and process adverse event reports to ensure accuracy and timely compliance with regulatory requirements
Conduct signal detection activities and support risk assessments to identify and evaluate potential safety concerns
Partner with cross-functional teams to address safety-related questions and support ongoing investigations
Maintain current knowledge of pharmacovigilance regulations, global safety guidelines, and industry standards

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
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

Fulltime

Graduate Pharmacovigilance Associate

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

Location

Poland , Warsaw

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in pharmacy, life sciences, or a related field
Strong attention to detail and organizational skills, with the ability to manage multiple tasks and prioritize effectively
Excellent communication and interpersonal skills, with the ability to work collaboratively in a team environment
Very good written and spoken English language, particularly in usage of medical terminology
Very good written and spoken Polish
Proficiency in Microsoft Office applications, with good analytical and problem-solving skills

Job Responsibility

Processing adverse events information in a global database based on source data using medical knowledge
Quality control of entered data, ensuring consistency and compliance with formal requirements
Substantive cooperation with international teams in order to ensure the highest quality of reporting and work efficiency
Participation in projects increasing the innovation of the Safety and Clinical Data Management Services
Participating in training and development activities to gain a deeper understanding of pharmacovigilance practices and regulatory requirements

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

Fulltime

Senior Pharmacovigilance Associate

We are currently seeking a Senior Pharmacovigilance Associate to join our divers...

Location

Brazil , Sao Paulo

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in life sciences, pharmacy, nursing, or a related field
High level of English proficiency
Based on Brazil - 100% remote position
Extensive experience in pharmacovigilance or drug safety, with a strong understanding of relevant regulations and industry standards
Proven ability to manage the pharmacovigilance process effectively, including adverse event reporting and signal detection
Strong analytical and critical thinking skills, with the ability to interpret complex data and make informed recommendations
Excellent communication and interpersonal skills, with the ability to work collaboratively across cross-functional teams
Proficiency in pharmacovigilance databases and data management systems, as well as Microsoft Office Suite
Ability to work independently and manage multiple priorities in a fast-paced environment
Commitment to maintaining confidentiality and handling sensitive patient information with discretion

Job Responsibility

Leading the collection, evaluation, and processing of adverse event reports to ensure timely and accurate reporting in accordance with regulatory guidelines and company policies
Conducting thorough data analysis and interpretation of safety data, identifying trends and potential safety signals that require further investigation
Preparing and submitting comprehensive periodic safety update reports (PSURs) and other regulatory documents, ensuring compliance with international regulations
Collaborating with medical and clinical teams to assess the clinical relevance of reported adverse events and contribute to risk management activities
Overseeing the maintenance and integrity of pharmacovigilance databases, ensuring accurate documentation and compliance with data management standards
Providing training and mentorship to junior team members on pharmacovigilance processes, regulatory requirements, and best practices
Engaging in audits and inspections conducted by regulatory authorities, ensuring readiness and compliance with all relevant pharmacovigilance requirements
Staying informed on evolving regulatory guidelines and industry best practices to continually enhance the pharmacovigilance processes within the organization

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

Fulltime

New

Patient Access Liaison - Site of Care - Rare Disease

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

Location

United States of America , Chicago

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

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

New

Patient Access Liaison- Rare Disease

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

Location

United States , Chicago

Salary:

158394.00 - 222256.00 USD / Year

Amgen

Expiration Date

August 03, 2026

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

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

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Pharmacovigilance Associate I

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