As a key member of the Product Safety and Pharmacovigilance team the Safety Scientist is primarily responsible for ensuring the continuous evaluation and management of product safety risks supporting regulatory compliance and patient protection through data analysis reporting and collaboration with safety physicians. The Safety Scientist also plays a key role in the quality management of pharmacovigilance system by preparing/managing SOPs participating in audits developing/managing CAPAs and communicating with pharmacovigilance vendors and global colleagues on system management.

As a key member of the Product Safety and Pharmacovigilance team the Safety Scientist is primarily responsible for ensuring the continuous evaluation and management of product safety risks supporting regulatory compliance and patient protection through data analysis reporting and collaboration with safety physicians. The Safety Scientist also plays a key role in the quality management of pharmacovigilance system by preparing/managing SOPs participating in audits developing/managing CAPAs and communicating with pharmacovigilance vendors and global colleagues on system management.

Responsibilities

• Coordinate signal detection activities including generating data presenting data meeting scheduling and management and assist with evaluation activities when requested.
• Prepare Safety Monitoring Plan (SMP) for clinical trials
• Liaise with clinical study teams and/or medical monitor to assist with the overseeing of safety monitoring of clinical trials.
• Conduct Periodic Adverse Drug Experience Report (PADER) process management including calls for contribution maintain PADER schedule coordinate document preparation/submission with Regulatory. Ensure regulatory compliance with aggregate safety reporting.
• Request and/or generate listings and CIOMS forms from the safety database for aggregate safety reports and signaling activities.
• Will co-author with Safety Physician: aggregate safety reports such as PBRER and other relevant safety documents such as RMP and REMS.
• Prepare semi-annual SUSAR line listing reports for clinical studies.
• In collaboration with the team contribute to and help coordinate responses to safety questions from regulatory authorities and generation of ad hoc safety reports for assigned products.
• Conducts quality review of ICSRs. Generate listing for similar case analysis for SUSARs as necessary.
• Work closely with the PSPV case processing team to ensure consistent data entry processes across all products with the goal of producing high quality data for aggregate reports and signaling activities.
• Provide overview training on the LSMV safety database to new PSPV staff; keep the team informed of systems-related changes that impact case operations.
• Collaborate with the database hosting vendor to develop and implement system changes (e.g. product configuration protocol configuration user access changes etc.) as needed to support PSPV business needs.
• Liaise with global colleagues regarding the management of the safety database and systems.
• Liaise with database hosting vendor to ensure timely responses on Shionogis open incidents in accordance with work order(s)/service agreements.
• Participate in database user guide updates to provide systems related input/advice.
• Participate in management of SOPs/Work Instructions for process improvement and consistency regarding aggregate reporting clinical trial safety oversight signal management.
• Actively participates in regulatory inspections and internal audits and in collaboration with QA and Regulatory Affairs ensures appropriate and timely responses to findings Coordinates PV corrective action/preventive action (CAPA) plans ensure appropriate root-cause analysis and documentation.
• Co-author PVA with license partners and vendors in collaboration with PSPV Manager. Coordinates and monitors the implementation of PV agreements (clauses) with all license partners and vendors and continuously monitor performance and compliance.
• Other Duties as needed.

Minimum Job Requirements

Qualifications/Experience

• Bachelors degree or Nursing (RN/BSN or RN/BS in related area) required.
• Advanced degree in a healthcare discipline (e.g. Masters PharmD) preferred.
• 4 years of experience in ICSR management.
• 2 years of aggregate safety report writing and safety signal management within a pharmaceutical company or equivalent setting.
• Proven background in clinical trial drug safety with the ability to understand interpret analyze and present scientific and medical data (both verbally and in writing).
• 4 years of hands-on experience with safety databases software such as Argus Safety .
• 2 years of experience with signal detection and pharmacovigilance processes.
• 2 years of experience with oversight of vendor relationships and alliances to ensure compliance and high-quality support.
• Comprehensive understanding of drug safety regulations including US FDA and EU GVP guidelines.
• Knowledge of applicable clinical trial and post-marketing safety regulations case processing expedited reporting rules and safety database concepts.
• Experience of preparing safety reporting and inspection readiness.
• Proficiency in common data processing software (Microsoft Excel PowerPoint Word Business Objects).
• Familiarity with standard safety database systems.
• Understanding of quality and risk management systems for pharmacovigilance system.

Other Requirements

Must live a commutable distance to our US Corporate Headquarters in Florham Park NJ. Office presence required 50% per month at least 2-3 days per week.

Competencies

• Proficient in managing safety systems processes and tools to ensure compliance and efficiency.
• Strong interpersonal and organizational skills with the ability to prioritize independently and manage multiple projects simultaneously.
• Detail-oriented and self-motivated with a focus on continuous improvement and adoption of best practices.
• Ability to work effectively in a team environment and adhere to written policies and procedures.
• Proven ability to collaborate with global teams cross-functional partners and regulatory authorities.
• Excellent communication and presentation skills.

Additional Information

The base salary range for this full-time position is $100000 - $130000. Individual pay is determined by several factors which include but are not limited to: job-related skills experience and relevant education or training. The range does not include the comprehensive benefits bonus long-term incentive applicable allowances or any additional compensation that may be associated with this role.

Shionogi Inc. is an equal opportunity employer supporting individuals with disabilities and veterans. All qualified applicants will receive equal consideration for employment opportunities based on valid job requirements without regard to race color religion sex (including pregnancy) marital status national origin age ancestry citizenship disability genetic information status as a disabled veteran a recently separated veteran Active Duty Wartime or Campaign Badge Veterans and Armed Forces Service Medal Veterans or any other characteristic protected by applicable law. It is the policy of Shionogi Inc. to undertake affirmative action for protected veterans and individuals with disabilities in compliance with all federal state and local requirements to recruit a diverse pool of protected veteran and individuals with disabilities applicants and to ensure that our employment practices are in fact non-discriminatory.

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