Principal Safety Scientist

Safety ScientistPrincipal Safety Scientist Remote Poland or Bulgaria

ICON plc is a worldleading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

ICON is seeking a PV Scientist to join their team and assist with the ongoing workload supporting their Global client and working closely with client’s MDs.

Ideally, previous experience will include, but is not limited to, the following therapy areas:
Rare Diseases, Hematology, Gastro Intestinal, Diabetes, Hypertension, Internal Medicine, ADHD, Oncology, Surgical Patches, Wound Healing, Parkinson’s Disease, Pain Management.

Responsibilities:

Activities includes postmarketing signal detection and signal management, input and review of risk management plans, aggregate safety reports, support of regulatory requests and global and local labeling.

Signal Detection, Evaluation, and Management:

• Perform proactive safety monitoring and signal detection for marketed products including signal identification, evaluation, interpretation of safety signals and prioritizing signals for full evaluation.
• Complete initial assessment of safety signals and prepare draft interpretation of reviewed data for assessing safety signals.
• Evaluates and prepares documents to answer internal andor external requests on safety data including the IB, labeling, aggregate reports, and regulatory submissions.
• Plan and execute literature surveillance as needed.

• Risk Management Plans:

  • Review of RMPREMS including aRMMs and provide input as needed
  • Risk Management Activities for postapproval of coredesignated core and EU RMPs.

  • Periodic (Aggregate) Safety Reporting:

    • Provides input and review for aggregate reports for submission to the health authorities and other stakeholders, as needed. Specifically PBRERs, PADERs, ACOs, local safety summary reports, etc.

    • Additional Responsibilities:

      • Review of Regulatory Authority Websites as pertaining to signal information.
      • Review of Local Labeling USPI & SmPC.
      • Responsible for responses to Health Authorities’ requests and responses to inquiries from internal and external customers.

      • Basic Requirements:

        • Scientific or Healthcare background (RN, PharmD, Ph.D).
        • Minimum 5 years relevant pharmaceuticalbiotech industry experience in Pharmacovigilance.
        • Safety Surveillance, specifically post marketing signal detection and risk management experience.
        • Excellent understanding of PV regulatory environment with working knowledge of FDA, EMA and ICH regulations and Good Pharmacovigilance (GVP).
        • Working knowledge of ARGUS.
        • Working knowledge of MedDRA codings.

        • Professional Competencies:

          • Good time management skills, able to prioritise workload accordingly.
          • Complies with all relevant safety and GxP procedures.
          • Ability to work independently to manage safety responsibilities and as part of a team.

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            What ICON can offer you:

            Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

            In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on wellbeing and work life balance opportunities for you and your family.

            Our benefits examples include:

            • 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, TELUS Health, offering 24hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s wellbeing.

            • Life assurance

            • Flexible countryspecific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

            • Visit our careers site to read more about the benefits ICON offers.

              At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

              If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

              Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

              Are you a current ICON Employee? Please click here to apply