Safety Scientist - Client-dedicated - Office or home based, Bulgaria ICON plc is a world-leading 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 post-marketing 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 and/or 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 RMP/REMS including aRMMs and provide input as needed Risk Management Activities for post-approval of core/designated 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 pharmaceutical/biotech 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 andICH 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 safetyand GxP procedures Ability to work independently to manage safety responsibilities and as part of a team 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 well-being 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, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.
Visit our careers site to read more about the benefits ICON offers.
At ICON, diversity, inclusion & belonging are fundamental to our culture and values.
Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities.
We're proud of our diverse workforce and the work we've done to become a more inclusive organisation.
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.
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