Pharmacovigilance Physician Job at PrimeVigilance (Guildford)

Senior Physician, Patient Safety

Join our dynamic Patient Safety team as a Senior Physician where you'll leverage...

Location

United States; Canada , Remote; Alberta

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
Good knowledge of drug safety and the drug development process
Good knowledge/understanding of medical terminology
Relevant experience in pharmacovigilance/ Drug Safety/ Clinical Practice
3 - 5 years previous experience in pharmacovigilance and/or medical monitoring is required
US Board Certification/board eligibility or regional equivalent for Canada
Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD)/ Medically qualified from an acknowledged Medical School
Completion of at least basic training in clinical medicine (residency, internship etc.)
Demonstrated success in technical proficiency and scientific creativity
Good presentation and verbal/written communication skills

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
Performing medical review of cases not limited to (including complex and challenging cases requiring expert judgement)), clinical trial, and literature cases including combination products {drug-device}) according to client/Parexel Standard Operating Procedures (SOPs
as applicable) and liaising with the client, as require
Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
Review appropriateness of medical content in narrative for medical coherence
Assessing seriousness, listedness / expectedness of reported events
Providing medical inputs to case processing team
Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional)
Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative

What we offer

Flexible approach to work that meets your personal needs
Work from home
Benefits vary by country
Investment in your professional and personal development

Study Physician - Oncology - FSP

The Study Physician (SP) is a critical global role that is created to take up me...

Location

United States

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook)
Proficiency in written and spoken English and (local language)
Excellent interpersonal, active listening and influencing skills
Pronounced analytical skills and systematic and well-structured working style
Pronounced presentation and training skills
Capability to work proactively and with team spirit in an international environment
Ability to use digital technologies to access information, be creative, innovate, solve problems, communicate, navigate, learn & apply in a digital environment
Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities
Understanding of relevant regulations and guidance including ICH-GCP
Experienced with data visualization systems and IT systems

Job Responsibility

Trial Start-Up: Responsible for medical content of Clinical Trial Protocols (CTPs)
Contribution to trial risk-based quality management from medical perspective
Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP)
Responsible for providing medical input into the definition of important protocol deviations (iPD)
Contribution to the timely preparation of medically relevant core trial documents and timely milestones
Medical input into Data Management documentation for the trial
Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan
Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report
Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs
Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans

Clinical Study Physician - Oncology

Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is ...

Location

United States , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Physician MD, ideally with medical thesis, trained in a clinical setting
Minimum of 4 years of active clinical experience
specialization in internal medicine or general practice preferred
Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development, with required capabilities
Understanding of relevant regulations and guidance including ICH-GCP
Experienced with data visualization systems and IT systems
Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook)
Proficiency in written and spoken English and (local language)
Excellent interpersonal, active listening and influencing skills
Pronounced analytical skills and systematic and well-structured working style

Job Responsibility

Trial Start-Up: Responsible for medical content of Clinical Trial Protocols (CTPs)
Contribution to trial risk-based quality management from medical perspective
Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP)
Responsible for providing medical input into the definition of important protocol deviations (iPD)
Contribution to the timely preparation of medically relevant core trial documents and timely milestones
Medical input into Data Management documentation for the trial
Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan
Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report
Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs
Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans

What we offer

Parexel offers a flexible approach to work that meets your personal needs while maintaining quality delivery for patients. Choose the right work arrangement for you - in-office, home-based or a mix
Benefits vary by country, but Parexel is passionate about our team’s overall wellness
We believe that investing in your professional and personal development is an investment in Parexel, and we want to help you realize your full potential and career

Clinical Study Physician - Oncology - FSP

Parexel FSP has an exciting opportunity for a Clinical Study Physician. This is ...

Location

United States , Remote

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Physician MD, ideally with medical thesis, trained in a clinical setting
Minimum of 4 years of active clinical experience
specialization in internal medicine or general practice preferred
Experience in the pharma industry or CRO in medical, project management or global pharmacovigilance functions/any other relevant medical function, ideally in Clinical Development
Understanding of relevant regulations and guidance including ICH-GCP
Experienced with data visualization systems and IT systems
Proficiency with Windows, MS Office (Word, PowerPoint, Excel, Outlook)
Proficiency in written and spoken English and (local language)
Excellent interpersonal, active listening and influencing skills
Pronounced analytical skills and systematic and well-structured working style

Job Responsibility

Trial Start-Up: Responsible for medical content of Clinical Trial Protocols (CTPs)
Contribution to trial risk-based quality management from medical perspective
Medical responsibility as co-author for the development of a robust Clinical Quality Monitoring Plan (CQMP)
Responsible for providing medical input into the definition of important protocol deviations (iPD)
Contribution to the timely preparation of medically relevant core trial documents and timely milestones
Medical input into Data Management documentation for the trial
Responsible for the medical content of Patient Information and Informed Consent, Trial Level Monitoring Manual, Trial Communication Plan, Trial Training Plan, and Trial Statistical Analysis Plan
Medical contribution to Patient Narrative preparation, Clinical Trial Report planning and review of medical sections of Clinical Trial Report
Contribute to the medical content of responses to questions from regulators and Ethic Committees/IRBs
Medical input to study and site feasibility in planning and execution, patient recruitment, and retention plans

What we offer

Flexible approach to work that meets your personal needs while maintaining quality delivery for patients
Choose the right work arrangement for you - in-office, home-based or a mix
Benefits vary by country, but Parexel is passionate about our team’s overall wellness
Investing in your professional and personal development is an investment in Parexel, and we want to help you realize your full potential and career

Fulltime

Study Physician - Oncology trials

Parexel is currently seeking an experienced Study Physician to join us in German...

Location

Germany

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Physician (MD) (ideally with medical thesis)
Trained in a clinical setting
Minimum of 4 years of active clinical practice experience
Specialization in internal medicine or general practice is desirable
Experience in pharma industry or CRO in medical or project management or global pharmacovigilance functions/ any other relevant medical function ideally in Clinical Development is desirable
Understanding of relevant regulations and guidance including ICH-GCP
Ideally experienced with data visualization systems and IT systems
Clinical development/trials experience

Job Responsibility

Medically responsible at the trial level throughout the preparation, conduct and reporting phase of clinical trial
Provide medical expertise and medical oversight from the Trial Design Outline to the Clinical Trial Report
Ensure timely preparation of high medical quality clinical trial protocols, minimising protocol amendments
Contribute to trial risk based quality management, by defining medically relevant data and related risks are integrated into the quality and risk management plan
Co-author Clinical Quality Monitoring plans
Performing ongoing reviews of medical data

Key Account Manager aHUS

Proclinical is seeking a Key Account Manager to join a dynamic team focused on r...

Location

Germany , München

Salary:

Not provided

Proclinical

Expiration Date

Until further notice

Requirements

Background in biotechnology or pharmaceutical sales, preferably in the orphan market
Master's degree in biology, Chemistry, or a related field with a strong sales mindset
Ability to work independently and collaboratively in a team-oriented environment
Experience in managing scientific events and projects
Strong relationship-building skills with healthcare providers in both community and academic settings
Effective presentation and communication skills with the ability to address customer needs and concerns
Flexibility to work across different indications and target groups as required
Proficiency in Microsoft Office tools (Outlook, PowerPoint, Word, Excel) and reporting systems
Knowledge of pharmaceutical regulations in the country
Willingness to travel regularly within the territory, including overnight stays

Job Responsibility

Build and maintain relationships with office-based and hospital nephrologists, pharmacists, nurses, and other relevant healthcare professionals
Develop a positive image of the company among key customer groups
Analyze the region to identify and develop centers specializing in rare diseases in nephrology
Provide educational and commercial services to physicians and pharmacies
Promote products in alignment with marketing and sales strategies while adhering to legal and compliance guidelines
Plan, organize, and execute local educational sessions for healthcare professionals
Collaborate cross-functionally with marketing, medical science liaisons, and other teams to ensure cohesive account management
Maintain accurate records in the CRM database and provide timely reporting to senior management
Collect and report pharmacovigilance information as per internal procedures
Represent the territory in reviews, account planning discussions, and at national/international events and congresses

Fulltime

Associate Director, Pharmacovigilance Scientist

The Associate Director, Pharmacovigilance Scientist will provide leadership, gui...

Location

United States , Waltham

Salary:

160000.00 - 200000.00 USD / Year

Kailera Therapeutics

Expiration Date

Until further notice

Requirements

A minimum of 10+ years of experience in global pharmacovigilance in pharmaceutical, biotech, or CRO setting with a Bachelors degree or 5+ years of experience with an advanced degree
Experience in safety data analysis, signal management, and benefit-risk evaluation
Knowledge of safety databases (Argus, ArisG/LifeSphere Safety, Veeva or similar), ICSR workflows, and MedDRA coding
Experience with authoring or contributing to aggregate safety reports, signal assessment reports
Working knowledge of relevant local and global regulatory requirements and guidance documents
Experience in creating or managing SOPs or Work Instructions
Strong ability to proactively identify signals, trends, risks, and initiate/manage risk minimization activities
Strong ability to work independently and collaboratively with internal and external partners in a demanding environment
Ability to prioritize, multitask, and deliver quality results that meet tight timelines
Fluency in written and spoken English with strong ability to communicate complex issues clearly

Job Responsibility

Perform and coordinate complex benefit-risk assessment and safety surveillance activities
Serve as a critical contributor to the safety governance framework, prepare safety data for review, coordinate and attend Safety Management Team and Medical Safety Board meetings
Coordinate and support strategies for safety assessments in collaboration with the safety physician and medical development as applicable
Lead and contribute to the management of aggregate safety reports (e.g., DSURs, PBRERs, PADERs, periodic line listings) including scheduling, planning, and authoring assigned sections
Collaborate with cross-functional teams to regularly review emerging safety data for the purposes of trend analysis and/or signal detection as applicable
Contribute to the preparation of queries in the safety database, retrieve and present data for regular and ad-hoc safety reviews
Perform safety signal management activities
conduct signal detection, author signal validation/evaluation reports, track and communicate findings
Collaborate cross functionally to access and utilize data visualization and analysis tools for regular and ad-hoc safety reviews
Lead or assist with the preparation of Risk Management Plans (RMPs)

What we offer

Comprehensive health benefits and tax-advantaged savings accounts
Flexible time off, 13 paid holidays, and a companywide year-end shutdown
Monthly wellness stipend
Generous 401(k) match
Disability and life insurance

Fulltime

Medical Information Associate

The PrimeVigilance Medical Information Associate position offers an opportunity ...

Location

United Kingdom , Guildford

Salary:

Not provided

PrimeVigilance

Expiration Date

Until further notice

Requirements

An undergraduate degree in life sciences
Customer service experience is an advantage
Advanced knowledge of English plus one other language
Advanced knowledge of MS Word and Excel
Excellent attention to detail and organizational skills
Independent problem solving and decision-making skills
Process-oriented and critical thinking
Responsible approach to work duties

Job Responsibility

To take responsibility for handling medical information inquiries in English and ideally one other language in which you are fluent
To take responsibility for translational activities in your other fluent language, where applicable
To provide approved responses to medical inquiries from external customers including healthcare professionals and patients as well as assisting the pharmaceutical clients’ internal departments with queries where required
To prepare responses to inquiries based on research in the literature and collaboration with physicians both internally and with pharmaceutical client internal departments
To participate in the out-of-hours provision of medical information for clients who have contracted a 24/7 inquiry handling service

Pharmacovigilance Physician

PrimeVigilance

Location:
United Kingdom , Guildford

Category:
Pharmacy

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
December 11, 2025

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