Job Title - Associate Director, Senior Patient Safety Scientist
Career Level - E
Introduction to role
Are you ready to lead the charge in ensuring patient safety and making a real difference? As an Associate Director, Senior Patient Safety Scientist, you will spearhead the review of safety data and related documents for potential safety issues in collaboration with the Global Safety Physician (GSP) and Patient Safety Scientist. You will author and lead PV input to safety documents and regulatory reports, lead meetings, and present safety data and analyses. Join us in our mission to deliver life-changing medicines to patients worldwide.
Accountabilities
* Lead and/or conduct proactive pharmacovigilance and risk management planning for more complex products, including preparation of the safety aspects of Global Risk Management Plans (RMP) and/or Risk Evaluation and Mitigation Strategies (REMS) in partnership with the GSP and others as appropriate.
* Lead PS activities of cross-functional project teams for marketed products and/or developmental compounds.
* Provide safety expertise to Investigator Brochures and Protocols, Informed Consents, and Clinical Study Reports.
* Perform duties as a Safety Strategy and Management Team (SSaMT) Leader for larger or more complex projects.
* Present complex issues to the Safety Information Review Committee (SIRC) and take the lead role in data evaluation and discussion of the results with the SIRC Chair, GSP, and other key stakeholders.
* Collaborate with GSP and Clinical representatives to author the Reference Safety Information (RSI) for multiple or complex marketed products and/or development products.
* Author/provide strategic input or oversight for multiple or complex periodic regulatory documents (PBRERs, PSURs, DSURs) according to the agreed process and timelines.
* Participate in negotiations and provide expertise to the PS component of contracts/agreements with third parties to ensure quality and integrity of agreements.
* Train and mentor junior members of the team in approved PV processes, analytic methodologies, etc.
* Author/provide strategic leadership to regulatory submissions for new products, formulations, or indications (NDA/BLA, MAA), in partnership with the GSP and other functional experts.
Essential Skills/Experience
* Qualified to degree level in biosciences or an equivalent healthcare or pharmaceutical industry background, with proven competency in patient safety/clinical development.
* Comprehensive understanding of applicable Patient Safety regulatory obligations.
* Awareness of Patient Safety policies, processes, and procedures.
* Awareness of medico-legal aspects of patient safety.
* 11 to 13 years Patient Safety experience (Pharmacovigilance).
* Total of 14 to 16 years of experience.
Desirable Skills/Experience
* Well-developed interpersonal skills.
* Cultural sensitivity.
* Ability to network with other functions globally.
Ready to make an impact? Apply now!
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