Safety Risk Management Lead

Description du poste:

PURPOSE OF THE FUNCTION:

* Perform and support Global Patient Safety activities including generation, review, and presentation of aggregate safety data, and assist with the assigned activities of Global Medical Safety Leads (GSLs).
* Conduct safety signal detection and management.

ROLES AND RESPONSIBILITIES:

* Provides safety expertise, state of the art pharmacovigilance, and safety risk management for assigned products (marketed or in development)
* Perform ongoing review of emerging safety data from various sources including individual case safety reports, published literature, aggregate reports, and other sources.
* Lead and perform safety signal management activities including detection, validation, prioritization, evaluation, confirmation or refutation, and the tracking of risk mitigation and minimization actions using Oracle Empirica Signal and Topic.
* Ensure the compliant functioning of Empirica by collaborating with Oracle and cross-functionally within argenx.
* Assist GPS GSLs in their assessment of medical safety data for assigned products, development and execution of safety signal and benefit-risk management strategies and closely collaborate with stakeholders internally.
* Prepare data for and actively participate in safety governance processes including Safety Management Teams (SMT) and Benefit-Risk Committees (BRC).
* Effectively lead, oversee and participate in the planning, preparation and review of periodic safety reports (e.g. DSUR, PSUR, PADER)
* Participate in the presentation and analysis of safety data from on-going and completed clinical trials and from post-marketing sources.
* As needed, review and provide safety input, for key study-related documents, e.g. protocols, Investigator's Brochure (IB), or Informed Consent Form (ICF).
* Participate in departmental development activities including SOP and Work Instructions development
* Perform other activities as needed to assist with departmental activities

SKILLS AND COMPETENCIES:

* Knowledge of pharmacovigilance as applies to safety signal management, safety data review in clinical and post-marketing settings
* Knowledge of relevant global pharmacovigilance regulations and guidelines
* Demonstrated ability to prepare and/or review high quality safety documents, including aggregate safety reports, signal validation/evaluation reports, or risk management plans
* Working knowledge of Oracle Empirica. Experience with other safety signal management tools is a plus
* Understanding of the principles of databases, querying data sources as well as developing and applying search strategies
* Ability to communicate complex issues effectively
* Ability to influence and collaborate with multidisciplinary teams
* Ability to prioritize and plan proactively
* Excellent analytical and problem-solving skills, with autonomy and applied judgment
* Working knowledge of MedDRA. Experience with WHO Drug Dictionary is a plus
* Relevant computer skills including proficiency with Microsoft Office
* Fluency in written and spoken English

EDUCATION, EXPERIENCE AND QUALIFICATIONS:

* Bachelor's or Master's degree in pharmacy, nursing, healthcare or other life sciences or technical fields (Ph. D. or M.D a plus)
* Minimum of 3-5 years of relevant pharmaceutical/biotech industry or healthcare experience
* Pharmacovigilance/safety risk management experience is strongly preferred