Pharmacovigilance Assistant Job at PrimeVigilance (Guildford)

Pharmacovigilance Assistant

We are currently seeking an Administrative Assistant to join our diverse and dyn...

Location

Poland; Bulgaria , Warsaw; Sofia

Salary:

Not provided

iconplc

Expiration Date

Until further notice

Requirements

Bachelor’s degree in life sciences, pharmacy, or a related field or equivalent experience in an administrative role (any industry)
Basic understanding of pharmacovigilance principles and regulatory requirements is advantageous but not essential
Strong attention to detail and organizational skills, with the ability to manage multiple tasks efficiently
Effective communication and collaboration skills, with a focus on maintaining accuracy in documentation and reporting
Ability to work in a fast-paced, regulated environment, ensuring compliance with safety guidelines and protocols
Excellent computer skills (Microsoft Word, Excel, Outlook, PowerPoint)
Fluent in written and verbal English
Ability to work effectively independently and within a team environment and across global teams

Job Responsibility

Complete all departmental project activities accurately in accordance with ICON SOPs, Project Specific Procedures, regulatory requirements, and Sponsors processes
Provide administrative support to project teams as required
Distribute reports to Sponsors, sites, and applicable ICON personnel
Coordinate setup of required systems and mailboxes during study startup
File all documents within allotted timeframes, including maintenance of project mailboxes and maintenance of TMF and E-TMF
Maintain data entry for safety event and miscellaneous tracking logs for all current projects
Assist with organization and planning of meetings
Daily entry into, and maintenance of, appropriate tracking systems
Maintain project training records for all assigned project team members
Handle Safety Reporting courier submissions to Competent Authorities and Ethics Committees

What we offer

Various annual leave entitlements
A range of health insurance offerings
Competitive retirement planning offerings
Global Employee Assistance Programme, LifeWorks
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments

Fulltime

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

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 Physician, Patient Safety

Location

India

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

MBBS or MD from a recognized medical school
2+ years of experience in ICSR medical review
Good understanding of medical terminology
Experience in pharmacovigilance, drug safety, or clinical practice
Basic clinical training (internship/residency completed)

Job Responsibility

Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
Communicating and discussing issues related to review process with Line Manager/ Project Leader/Designee
Interacting with internal and external stakeholders for resolving issues
Attending and/ or presenting at client/cross functional meetings along with other stakeholders
Working as Subject Matter Experts (SMEs)
Assisting the Project Lead/Functional Lead for audits and inspections
Provides inputs for process improvements
Works closely with Project Lead/Functional Lead for process co-ordination and to ensure meeting all Key Performance Indicators (KPIs) for the process
Function as pharmacovigilance representative/safety scientist

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

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

Patient Access Liaison

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

Location

United States , Fresno

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

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Pharmacovigilance Assistant

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