Safety Scientist/Principal Safety Scientist

Safety Scientist/Principal Safety Scientist - Remote - Poland or 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 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:

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.

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