Pharmacovigilance Reporting Specialist
Galderma Laboratories

Job Info

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Company Overview
Galderma, the world's largest independent global dermatology company, was created in 1981 and is now present in over 100 countries with an extensive product portfolio of prescription medicines, aesthetics solutions and consumer care products. The company partners with health care practitioners around the world to meet the skin health needs of people throughout their lifetime. Galderma is a leader in research and development of scientifically-defined and medically-proven solutions for the skin. For more information, please visit www.galderma.com

Job Description
The PV Reporting Specialist plays a key role within the PVRM organization at Galderma in ensuring timely safety regulatory submissions, compliance with PV regulation requirements and by gathering quantitative metrics that are extremely relevant for assessing the performance and compliance of a PV system.

Primary Responsibilities: Delivers global safety reporting services, including expedited and periodic safety reporting to Competent Authorities (CA) and Central Ethics Committees (CEC), for investigational medicinal products (IMPs) according to ICH-GCP guidelines, per regulatory requirements and Galderma Standard Operating Procedures (SOPs) and/or project specific procedures.

Job Responsibilities

• Review, preparation, and submission of safety reports (Expedited and Periodic) to all applicable Competent Authorities and Central Ethics Committees within defined timelines for a given IMP.
• Contribute to the generation and maintenance of the global safety reporting plan for individual studies.
• Maintain oversight of third-party vendors and timely compliance reconciliation of vendor submissions.
• Maintains a high level of understanding of applicable safety reporting regulations (e.g., FDA and ICH guidance, GCP regulations, EU Directives, country specific requirements etc.).
• Maintains an up-to-date central filing system of pertinent safety documents and submissions.
• Submits expedited and periodic safety reports to business partners, Competent Authorities and Ethics Committees as applicable according to Galderma SOPs and the project specific safety reporting plan including any country specific reporting requirements.
• Distributes final regulatory reports to Clinical Operations or designee for reporting to Investigators and/or local IRBs/ECs.
• Submits SUSARs electronically through ARGUS Gateway.
• Liaises with applicable departments at Galderma and/ or vendor or service provider to ensure timely submission of Expedited and Periodic reports to applicable Regulatory Authorities and Ethics Committees and ensure all submissions are tracking appropriately and filed in the project folder
• Escalates issues identified in reporting and processing of SUSARs and SAEs to Galderma Vigilance systems administrator.
• Provides input and review of responses to regulatory agency questions with regard to Galderma compliance and to safety reporting requirements and tracking.
• Maintains awareness of reporting timelines for aggregate safety reports.
• Tracks regulatory submissions in the safety database or project specific tracking tool, as applicable.
• Assists in conducting root cause analysis for any late regulatory reports, audits, and inspections as required/appropriate
• Performs vendor compliance reconciliation as required per project.
• Attends internal and client project team meetings and provides relevant team updates as required.
• Assists in the development, maintenance and update of Standard Operating Procedures (SOPs) and/or Working Instructions (WIs) or other guidance documents related to safety reporting, including those that are study specific.
• Supports departmental process improvement initiatives and collaborates with relevant departments to ensure execution.
• Supports business development activities, budget, and proposal input, etc., as required.
• Mentors and/or trains other safety reporting staff, as applicable.
• Performs other duties as assigned by the Manager.
• Assists in the development, maintenance and update of Standard Operating Procedures (SOPs) and/or Working Instructions (WIs) or other guidance documents related to safety reporting, including those that are study specific.
• Supports departmental process improvement initiatives and collaborates with relevant departments to ensure execution.
• Supports business development activities, budget, and proposal input, etc., as required.
• Mentors and/or trains other safety reporting staff, as applicable.
• Performs other duties as assigned by the Manager.

Minimum Requirements

• Bachelor's Degree in one of the life sciences or nursing.
• Fluent in English.
• A minimum of 3 to 4 years of global pharmacovigilance experience with at least 2 years of relevant experience in regulatory authority submission of clinical study ICSRs. Excellent knowledge of the clinical research process and current GCP/ICH guidelines applicable to conduct of clinical research.
• Excellent knowledge of safety databases and electronic reporting systems (Argus).
• Computer literacy and experience working with Microsoft Office (Word, Excel, Teams, Outlook and PowerPoint) required.
• Excellent written and verbal communication and presentation skills.
• Excellent organization skills and ability to handle multiple priorities while adhering to applicable timelines.
• Positive attitude and ability to interact with all levels of staff to successfully coordinate and execute safety reporting activities.
• Flexibility to take on additional assignments as required and as the role develops.
• Eagerness to learn and to share knowledge with team members both internal and external to the company.
• Strong set of problem-solving skills utilizing creative thinking to make informed decisions using thoughtful analysis
• Tolerance for change and uncertainty.
• Prioritizes time effectively based on project needs.
• Seeks management input with any difficulties in establishing priorities.
• Consistently meets deadlines.
• Ability to understand, evaluate and follow regulatory legislation and guidelines.
• Ability to work independently, follow instructions/guidelines and demonstrate initiative.

Other Important Information
The work environment characteristics and physical requirements described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing duties of this job, the employee may or may not be frequently/or occasionally required to:

• Stand; walk; sit; climb or balance; stoop; kneel; crouch; talk or hear; and taste or smell.
• Climb stairs or ride elevators.
• Lift and/or move up to 25 pounds.
• Use close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.
• Manipulate keyboard or otherwise access computer, telephone and hand-held devices.
• Be exposed to outside weather conditions while going in and out of office buildings.
• Be exposed to moderate noise level usually in warehouse settings.
• Be exposed to moving equipment, mechanical parts, and/or high places; or moving between air-conditioned and non-air-conditioned environments.
• Ability and willingness to travel domestically and internationally, if required (travel requirement <5%).

Where permitted by applicable law, successful applicants must be fully vaccinated against COVID-19 by their date of hire to be considered for employment. Proof of vaccination required.

Employer's Rights:

This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based upon your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not a contract for employment, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position

This job has expired.