Drug Safety Associate

As a DRUG SAFETY ASSOCIATE you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

 Based in Lithuania

Responsibilities

• Manage collection, processing, documentation, reporting and follow-up of all adverse event reports for all Novartis products from clinical trials, non-interventional studies, patient-oriented programs, literature, spontaneous reports, etc. Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality.
• Manage reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SR, IN/SUSAR, PSUR, biannual SUSAR listing, DSUR) to local Health Authorities and/or clinical operations in cooperation with other country organization departments.
• Work with other local/global Patient Safety Associates to ensure accurate evaluation of safety data.
• Interact and exchange relevant safety information with LHA, Patient Safety Associates, other functional groups and third-party contractor, if applicable.
• Survey and monitor national pharmacovigilance regulations and provide update to global patient safety organization.
• Develop, update and implement local procedures to ensure compliance with patient safety global procedures and national requirements.
• Input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information.
• Perform reconciliation with other departments (eg. Medical Information, Quality Assurance and third-party contractor, if applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources.
• Management and maintenance of all relevant patient safety databases.
• Prepare and submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to LHA, development and implementation of corrective action(s) as needed.
• Develop and update training materials for pharmacovigilance and ensure training of country organization associates on relevant patient safety procedures for AE reporting, including field force and third-party contractor, if applicable.
• Ensure support for and close-out of audits, corrective action plan, investigation and Health Authority inspections.
• Ensure training and oversight of staff, as applicable.
• Manage and maintain efficient patient safety filing and archive system.
• Review of all Phase IV Clinical Trial and NIS protocols safety sections and if a Contract Research Organization (CRO) is conducting the trial, review the contract (SSW), train the CRO associates responsible from the trial.
• Drives the local execution of the RMP for all Novartis group products in the applicable country organization:

• Ensures training on RMP principles and RMP product specifics of country organization staff (including sales/marketing staff) involved in the implementation of the RMP.
• Supports the drug safety responsible in the timely and compliant execution locally of the Pharmacovigilance activities defined in the RMP.
• Liaises with the other departments in the country organization such as clinical research operations, medical, regulatory affairs or sales/marketing to ensure alignment of all local functions in support of the RMP.
• Liaises with sales/marketing to ensure implementation of educational materials.

• Liaises with local RA to ensure tracking of status of the RMP commitments implemented locally.

Qualifications

• Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist).
• Fluent in both written and spoken English.
• Fluent in both written and spoken local language.
• Knowledge of national and international regulations for pharmacovigilance.
• Knowledge of pharmacological and medical terminology.
• Excellent communications, interpersonal and negotiation skills.
• Quality and focus oriented.
• Computer skills applicable to perform the services outlined above.
• Additional educational requirements as may be mandated by national requirements.

• #LI-Onsite

  #LI-OB1

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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.

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.