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Principal Pharmacovigilance Safety Scientist, Global Pharmacovigilance
Durham, NC 27703 United States
Looking for a high energy pharmacovigilance professional wanting to make the next step up. This is an opportunity to join a growing, 1st in class Pharmacovigilance CRO, located in North Carolina. Our organization that has a 17 year track record of success and looking to expand its horizons.
We are looking for a motivated, results oriented subject matter expert with a love for mentoring to assume a project lead, principal author, senior/subject matter expert role within the Safety Scientist group.
Provide pharmacovigilance (PV) data analysis and writing expertise as required for preparation of a range of US and global regulatory reports, including PBRER, PSURS,INDSRS and Signal Detection issues. Responsible for data compilation, validation, evaluation and written conclusions for aggregate safety documents consistent with Company and global regulatory requirements. This includes the scheduling, tracking, preparation and analysis of DSUR, PSUR, PADER, PBRER, trend analysis, signal detection reports and other ad hoc reports requested by clients.
Serve as mentor to other safety staff. Create educational packages, training material and tools related to pharmacovigilance, database use, safety signaling and other subjects necessary for skill development.
Duties may be related to documents and reports for any of the following areas: Branded and Generic Pharmaceuticals, OTC products, Consumer Health Products, or Animal Health Products. Identify and evaluate new safety signals and trends by conducting systematic reviews of aggregate data with a focus on spontaneous adverse event reports.
Perform signal triage using medical judgment. Perform, as needed, signal validation through analysis and evaluation of safety data, in consultation with the safety surveillance Medical Directors. Provide recommendations for further evaluation.
May participate as a member of the Safety Evaluation Committee to support signal detection activities and to address product specific safety issues.
Lead the development and implementation of programmatic surveillance of spontaneous adverse event reports for potential medical or product quality issues. Lead the evaluation of novel and computer-assisted tools and methodologies for analysis of safety data.
Must be prepared to lead safety surveillance and escalate safety signal observations and alerts, and/or recommend medical safety assessments, risk monitoring, and product labeling or design changes.
Prepares aggregate reports summarizing safety data, making conclusions about safety signals (or lack thereof). The incumbent may or may not perform all functions in this summary.
• Lead the comprehensive workload planning and tracking for all safety scientist activities within an established database or comparable system.
• Participate and hold responsibility as the Safety Scientist, Safety Evaluation Committee member.
• Act as the key and focal contact point for new client onboarding and initial interaction involving the safety scientist function.
• Act as the key liaison involving the Business Development and Product Director functions for new clients’ proposals (RFP), and act as the subject matter expert in the role of Safety Scientist with respect to knowledge of DSA capabilities in the safety science area.
• Provide mentorship and coaching to new staff within the safety scientist function, as well as other new staff in the medical and risk management groups about the role of safety scientists and the deliverables and accountabilities of the function.
• Lead planning, preparing, writing and editing of cohesive, high quality drug safety reporting documents.
• Apply appropriate scientific interpretation of relevant information for inclusion in drug safety documents.
• Maintain a high level of client interaction, ensuring a solid understanding and knowledge of each client’s products.
• Collect and analyze adverse event data and identify potential safety signals.
• Evaluate literature and other appropriate data sources to understand the nature of adverse drug reactions. Summarize and include relevant information in aggregate reports.
• Ensure timely submission of reports to worldwide regulatory agencies in accordance with applicable regulations.
• Maintain current knowledge of global good pharmacovigilance practices through survey of relevant literature, attendance at meetings and use of external networks.
• Provide feedback to management on medical writing project timelines.
• Develop and implement aggregate reporting and medical writing WPs and SOPs to ensure efficient preparation of high quality medical writing deliverables.
• Implement workflow and document tools to streamline workflow process for aggregate reports and medical writing.
• Develop and maintain medical writing vendor relationships, as needed.
• Prepare and/or assist in special client reports as needed.
• Participate in internal and external audits, responding to any quality issues identified.
• Lead safety surveillance and escalate safety signal observations and alerts, and/or recommend medical safety assessments, risk monitoring and product labeling or design changes.
• Prepare aggregate reports summarizing safety data, making conclusions about safety signals (or lack thereof).
• Other duties as assigned.
Master’s Degree and Bachelor’s degree in a healthcare or scientific field with at least 10 years of experience in drug safety, safety data analysis, medical writing, or regulatory affairs is required. Global experience with or an equivalent combination of education and experience. Clinical experience and knowledge of pharmacology, pharmacy, physiology or other relevant scientific discipline is preferred. Subject matter expertise in at least two of the following proficiencies: Safety governance and risk management, signal detection and evaluation, regulatory reports and submissions, biostatistics, and aggregate report writing and evaluation.
Ability to work in an environment of rapidly changing priorities and workload; ability to manage multiple activities and assignments; ability to work both as a member of a team and in an independent, self-directed manner; ability to manage and organize work to meet timelines and to meet the attention of detail required to successfully complete assignments; ability to communicate effectively in English, both orally and in writing; ability to present information in front of groups of people; ability to maintain client and corporate confidentiality; ability to effectively negotiate with individuals at all levels of business; ability to make sound decisions relating to the advancement of the company mission and goals; ability to effectively interact with the multi-national community; and ability to proficiently utilize MS Office and other required software.
• Working knowledge of global regulatory safety reporting requirements.
• Proficient adverse event case management.
• Use of relevant drug safety databases.
• Search literature and appropriate data sources to understand the nature of adverse drug reactions.
• Proficient knowledge of MedDRA dictionary.
• Interpret, analyze and clearly present scientific and technical data in verbal and written format.
• Effectively interact with multiple cross functional departments to produce quality written documents.
• Work in an environment of rapidly changing priorities and workload.
• Strong time, project and resource management skills.
• Manage multiple activities and assignments.
• Work as a member of a team and in an independent, self-directed manner.
• Prioritize, manage and organize work to meet timelines.
• Attention to detail required to successfully complete assignments.
• Develop and review guidance documents, including SOPs and WPs.
• Review documents critically.
• Communicate effectively in English, both orally and in writing.
• Utilize sound decision-making skills to solve problems and troubleshoot issues in the area of expertise and job assignment.
• Maintain client and corporate confidentiality.
• Proficiently utilize MS Office and other required software.
North Carolina Biotechnology Center