Pharmacovigilance Physician Job at PrimeVigilance (Guildford)

Pharmacovigilance Physician

The Pharmacovigilance Physician will provide medical and clinical expertise, str...

Location

Poland , Warsaw

Salary:

Not provided

Theramex

Expiration Date

Until further notice

Requirements

Medical Doctor (MD) qualification
prior experience as EU QPPV or Deputy QPPV advantageous
previous experience in Drug Safety / Pharmacovigilance, with strong understanding of global PV regulations
demonstrated expertise in authoring and reviewing aggregate safety reports (RMPs, PSURs)
excellent medical writing skills and strong analytical ability
experience contributing to interventional and non‑interventional studies
proven ability to manage multiple strategic and operational projects simultaneously
strong influencing skills with the ability to engage stakeholders at all levels
hands‑on, proactive, self‑reliant working style with high attention to detail
ability to thrive in a fast‑paced environment with shifting priorities

Job Responsibility

Act as the global medical safety expert for all Theramex products
Lead Safety Monitoring Committee decision‑making
Drive signal detection, risk‑management activities, and prioritisation of mitigation strategies
Contribute to scientific evaluation of varied safety data sources
Author and/or review safety content for regulatory and clinical documents (PSURs, RMPs, SmPCs, PILs, protocols, HA responses)
Contribute to benefit–risk analyses across the portfolio
Maintain high standards of compliance with global pharmacovigilance regulations
Produce clear, fit‑for‑purpose signal evaluation documents for internal and external audiences
Interpret epidemiological and safety data to support product differentiation and informed decision‑making
Deliver training on safety or medical topics where needed

What we offer

A fast‑paced environment with broad exposure, where you can develop professionally – even outside your area of expertise
A culture that supports growth, encourages learning, and celebrates success
Opportunities for driven and talented professionals who want to be part of our purpose‑driven journey

Manager, Drug Safety Physician, Pharmacovigilance Epidemiology & Risk Management

Location

India , Noida

Salary:

Not provided

Cencora

Expiration Date

Until further notice

Requirements

Degree in Medicine
Minimum 3 years of relevant experience in Pharmacovigilance & Drug Safety
Strong interpersonal and organizational skills
High sense of responsibility, dedication, and desire to work under pressure
Highly service oriented
Good communication skills
Fluent in English- spoken and written
Previous exposure to corporate environment, pharma and life sciences industry is an advantage
PG degree in any discipline is an advantage but not mandatory

Job Responsibility

Conduct Medical Review and assessment of ICSR’s into the safety database
Review and verify appropriate selection of adverse events from source documents, check the seriousness criteria, appropriate MedDRA codlings, suspect drugs, concomitant medications, lab data, medical history, labelling, causality, review narrative and provide Company Clinical Comment
Review and respond to any queries/comments from the case owner in the patient safety database
Screening of scientific literature by using the internal search mechanism or by making use of external tools and providers
Maintain strong GPVP and GCP knowledge
Following ICH and EMA guidelines strongly and implementing them appropriately
Train and mentor PV associates on event capturing and general PV conventions as required
Acquire and maintain current knowledge of product and safety profiles for products across therapeutic areas
Escalate complex case issues on client products to Team Lead/Line Manager
Medical triage and Identification (Classification of references) of safety-relevant publications in scientific literature

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

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

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

SERM Scientific Director

Provides advanced scientific expertise in the safety evaluation and risk managem...

Location

United Kingdom , London

Salary:

111750.00 - 186250.00 EUR / Year

GSK

Expiration Date

Until further notice

Requirements

Degree in a health-related discipline (e.g., Life Sciences, Pharmacy, Medicine, Nursing), with significant relevant experience
Substantial experience in pharmacovigilance, drug safety, or a related function within the pharmaceutical or biotechnology industry
Experience supporting safety in oncology clinical development programmes
Strong expertise in: Signal detection and risk assessment
Clinical trial safety oversight
Regulatory safety documentation and submissions
Knowledge of global pharmacovigilance regulations (e.g., ICH, GVP, CIOMS)
Proven ability to work effectively in a complex, global matrix environment
Strong analytical, communication, and problem-solving skills

Job Responsibility

Lead pharmacovigilance activities and risk mitigation strategies for assigned oncology assets and clinical trials
Drive the evaluation and interpretation of safety data, including signal detection and assessment
Develop strategic approaches for safety issue evaluation within clinical development programmes
Contribute to safety components of global regulatory submissions (e.g., INDs, DSURs, IBs)
Perform literature review, clinical data synthesis, and integrated safety analyses to inform decision-making
Ensure high-quality, timely delivery while managing multiple priorities
Represent Safety Evaluation & Risk Management (SERM) on Clinical Matrix and Project Teams
Lead cross-functional efforts to address urgent and complex product safety issues
Partner closely with Safety Physicians and stakeholders to prepare for and contribute to Safety Review Team (SRT) meetings
Escalate emerging safety issues to senior leadership and governance bodies as appropriate

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes
Eligibility to participate in our share based long term incentive program

Fulltime

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Pharmacovigilance Physician

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