Senior Safety Physician

4 weeks ago

United Kingdom Skills Alliance Full time

Position: Senior Safety Physician
Description:
We are seeking a Senior Safety Physician to join our international team dedicated to ensuring the safety of our vaccine products. The team operates globally, with members based in Germany and the USA. Together, they conduct continuous data collection and assessment to manage the benefit-risk profile of our vaccines, whether authorized or still in clinical development.
Your role will involve leveraging your medical expertise and extensive knowledge of pharmacovigilance (PV) legislation to contribute to our team. We are looking for an individual who excels in analytical thinking, can navigate complex data, establish structured processes, and effectively communicate information across our global team.
Responsibilities:
Analyze comprehensive development and post-market product information, synthesize findings, conduct benefit-risk assessments, and generate reports including Risk Management Plans (RMP), Investigator's Brochure Safety Summaries (ISS), and aggregate reports.
Take primary ownership and accountability for product signaling review, analysis, delivery, and approval.
Proactively monitor product safety profiles from First-in-Human (FIH) trials throughout the product lifecycle.
Manage all medical safety aspects of assigned studies and post-market products, serving as the subject matter expert.
Lead and manage internal medical safety governance bodies, ensuring timely action and communication in safety governance forums.
Prepare for and support pharmacovigilance audits and inspections, focusing on product-specific medical safety aspects.
Provide medical safety oversight and key input to various documents including protocols, investigator brochures, safety summaries, clinical study reports, regulatory reports, and labeling.
Oversee and maintain Pharmacovigilance Agreement (PVA) and Safety Data Exchange Agreement (SDEA) management, as well as Contract Research Organization (CRO) management concerning medical safety processes.
Ensure all assigned medical safety activities comply with pharmacovigilance standard operating procedures (SOPs) and relevant guidelines.
Qualifications:
Medical degree (human medicine or veterinary medicine).
Minimum 6 years of experience in medical safety within a global role, preferably with experience in phase 3 and beyond.
In-depth knowledge of Good Pharmacovigilance Practices (GVP), FDA guidance documents, and global pharmacovigilance legislation.
Proficiency in safety databases and data visualization.
Fluent in English.
Effective communication and negotiation skills, with the ability to thrive in a matrix organization and solve complex problems.

  • Senior Research Physician

    1 day ago

    United Kingdom Pharmiweb Full time

    ABOUT USSimbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team. With a focus on...

  • Senior Research Physician

    2 weeks ago

    United Kingdom Simbec-Orion Group Full time

    ABOUT US Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers – headed up by a centralised leadership team. With a focus on...

  • Physician - Psychiatrist

    4 weeks ago

    United Kingdom St. Charles Health System Inc. Full time

    Physician Consult Liaison Psychiatrist page is loaded Physician Consult Liaison Psychiatrist Apply locations Bend, OR time type Full time posted on Posted 30+ Days Ago job requisition id R1015953 ST. CHARLES MEDICAL GROUP TITLE: SCMG Physician – Consult Liaison Physician/Psychiatrist Clinical Manager of Psychiatric Assessment Team (PAT) and...

  • Family Medicine Physician

    4 weeks ago

    United Kingdom Alberta Health Services Full time

    Family Medicine (Community/Primary Care) MED0002M6 Feb 27, 2024 Alberta Health Services, Central Zone, is actively recruiting a Family Medicine Physician to establish a full-time Family Medicine practice in the community of Consort. This position requires a rural scope of practice that includes: Community Clinic in Consort, Emergency Room Coverage 1:2...

  • Medical Director for Community Health Services

    4 weeks ago

    United Kingdom Highgate Senior Living Full time

    community, not a facility. we take a positive, holistic approach to senior care and encourage opportunity will allow you to positively impact the quality of life for over 700 seniors and their families. REGISTERED NURSE/HEALTHCARE DIRECTOR are looking for the right person to partner with our team to oversee and help implement the day-to-day nursing...

  • Physician Consult Liaison Psychiatrist

    4 weeks ago

    United Kingdom St. Charles Health System Inc. Full time

    Physician Consult Liaison Psychiatrist page is loaded Physician Consult Liaison Psychiatrist Apply locations Bend, OR time type Full time posted on Posted 30+ Days Ago job requisition id R1015953 ST. CHARLES MEDICAL GROUP PHYSICIAN JOB DESCRIPTION TITLE: SCMG Physician – Consult Liaison Physician/Psychiatrist REPORTS TO POSITION: Clinical Manager...

  • Physician Director

    3 weeks ago

    United Kingdom Immunocore Full time

    Director, Physician - Clinical Development, Early Oncology Vacancy Name Director, Physician - Clinical Development, Early Oncology Employment Type Full Time IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient...

  • Senior Research Physician

    3 weeks ago

    Merthyr Tydfil, , Merthyr Tydfil (Merthyr Tudful), Merthyr Tydfil, United Kingdom, Merthyr Tydfil (Merthyr Tudful), Merthyr Tydfil County Simbec-Orion Full time

    ABOUT USSimbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team. With a focus on...

  • Senior Clinical Scientist

    2 weeks ago

    United Kingdom ICON Strategic Solutions Full time

    As a Senior Clinical Scientist you will be supporting a global mid-sized biotech company. While being stably employed with ICON, you will be fully embedded with our client. Job Summary: Senior Clinical Scientist is responsible for working with the physicians within Clinical to provide clinical research support for programs as assigned by phase or...

  • Senior Clinical Scientist

    3 weeks ago

    United Kingdom ICON Strategic Solutions Full time

    As a Senior Clinical Scientist you will be supporting a global mid-sized biotech company. While being stably employed with ICON, you will be fully embedded with our client. Job Summary:Senior Clinical Scientist is responsible for working with the physicians within Clinical to provide clinical research support for programs as assigned by phase or therapeutic...

  • Senior Clinical Scientist

    3 weeks ago

    United Kingdom ICON Strategic Solutions Full time

    As a Senior Clinical Scientist you will be supporting a global mid-sized biotech company. While being stably employed with ICON, you will be fully embedded with our client. Job Summary: Senior Clinical Scientist is responsible for working with the physicians within Clinical to provide clinical research support for programs as assigned by phase or...

  • Senior Clinical Scientist

    3 weeks ago

    United Kingdom ICON Strategic Solutions Full time

    As a Senior Clinical Scientist you will be supporting a global mid-sized biotech company. While being stably employed with ICON, you will be fully embedded with our client. Job Summary:Senior Clinical Scientist is responsible for working with the physicians within Clinical to provide clinical research support for programs as assigned by phase or therapeutic...

  • Senior Clinical Scientist

    3 weeks ago

    United Kingdom ICON Strategic Solutions Full time

    As a Senior Clinical Scientist you will be supporting a global mid-sized biotech company. While being stably employed with ICON, you will be fully embedded with our client. Job Summary: Senior Clinical Scientist is responsible for working with the physicians within Clinical to provide clinical research support for programs as assigned by phase or...

  • Senior Clinical Scientist

    3 weeks ago

    United Kingdom ICON Strategic Solutions Full time

    As a Senior Clinical Scientist you will be supporting a global mid-sized biotech company. While being stably employed with ICON, you will be fully embedded with our client. Job Summary: Senior Clinical Scientist is responsible for working with the physicians within Clinical to provide clinical research support for programs as assigned by phase or...

  • Senior Clinical Scientist

    3 weeks ago

    United Kingdom ICON Strategic Solutions Full time

    As a Senior Clinical Scientist you will be supporting a global mid-sized biotech company. While being stably employed with ICON, you will be fully embedded with our client. Job Summary:Senior Clinical Scientist is responsible for working with the physicians within Clinical to provide clinical research support for programs as assigned by phase or therapeutic...

  • Senior Project Manager Data

    4 weeks ago

    United Kingdom Fortive Full time

    Job Description - Senior Project Manager (PRO000084) Senior Project Manager - PRO000084 Provation is a leading provider of healthcare software and SaaS solutions for clinical productivity, care coordination, quality reporting, and billing. Our purpose is to empower providers to deliver quality healthcare for all. Provation’s comprehensive portfolio...

  • Senior Safety Software Engineer

    4 weeks ago

    United Kingdom CONVENTUS SOLUTIONS LIMITED Full time

    Senior Software Safety Assurance Engineer :: Conventus Senior Software Safety Assurance Engineer Location: Hybrid Working across the UK Our client is looking to add a Senior Software Safety Assurance Engineer to their expanding team. Working with clients to develop and deliver safety-critical systems, we are looking for Engineers who have worked as...

  • Healthcare Director

    4 weeks ago

    United Kingdom Highgate Senior Living Full time

    LOVE YOUR WORK. JOIN OUR TEAM.  A community, not a facility. As thought leaders in the industry, we take a positive, holistic approach to senior care and encourage independence, as people are happiest when they can make their own choices. We provide opportunities for physical activity, social engagement, intellectual stimulation, spiritual involvement,...

  • Senior Project Manager

    1 week ago

    United Kingdom HSE Health and Safety Executive Full time

    This is an opportunity for a motivated person looking to build upon their Senior Project Manager skills and knowledge, working within the Building Safety Regulator (BSR) Programme. HSE is currently establishing the new Building Safety Regulator and this role will work across a multi-disciplinary team, including HSE and the Department of Levelling Up,...

  • Senior Safety

    2 weeks ago

    United Kingdom Defence Full time

    Senior Safety & Environmental Engineer The Senior Safety and Environmental Engineer would be joining the team in providing support . The principal support service would include the generation of systems and product Safety and Environmental Case documentation and through-life support products. As a Senior Safety and Environmental Engineer your...