Job description
This role will support our pharmaceutical portfolio. The Pharmacovigilance Operations Specialist is responsible for the implementation and maintenance of the pharmacovigilance (PV) requirements, under limited supervision.
Responsibilities:
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Support the pharmaceutical labeling process including but not limited to Global Safety Label Change and Global Safety Label Tracking
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Support worldwide pharmaceutical safety submissions (Periodic Safety Update Reports (PSUR), PSUR Addendum Statements (AS), US Periodic Safety Reports (PSR), Addendum to Clinical Overviews (ACO), Development Safety Update Reports (DSURs) and Risk Management Plans (RMPs)).
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Support the worldwide development and maintenance of the pharmaceutical Company Core Data Sheets (CCDS) including reference documents to the CCDS and the core safety information maintained within the CCDS.
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Works in close collaboration with internal stakeholders and supports multiple projects.
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Ensures compliance with global regulatory requirements and adherence to internal policies and processes.
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Responds to PV requests from across the organization in a timely manner.
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Provides high quality regulatory support for assigned products/projects.
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Develops documents that are clear, concise, and complete to facilitate reviews/approvals.
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Provides expertise to drug development teams on the development of labeling components for regulatory agency approval. Controls the consistency of labeling through review of content across the product family in alignment with the CCDS.
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Identifies areas of potential non-compliance and supports investigations as needed.
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Escalates issues pertaining to implementation of core labeling content (Company Core Data Sheet (CCDS, Reference, or Master labels) into product labeling to ensure compliance to regulations and standard processes.
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Works closely with Global Labeling Leads to ensure accurate and timely creation, approval, distribution, and implementation of core labeling documents (eg, CCDS, local labels).
Knowledge & Skills:
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Demonstrated ability to coordinate and work effectively with multiple stakeholders.
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Ensures timely, clear communications to internal stakeholders on project status and issues.
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Serves as role model and embraces corporate Values and Behaviors.
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Demonstrated good organizational and time management skills, including the ability to work on multiple projects and adhere to timelines.
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Meets individual goals as defined in the annual objectives.
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Ability to support the business by communicating effectively, managing issues proactively, resolving conflicts and mitigating risks.
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Ability to work in a matrixed environment and influence internal partners to achieve desired business outcomes.
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Strong writing skills in the form of high-quality regulatory submission documents.
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Committed to drive efficiency while maintaining quality.
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Drives superior results by taking initiative, planning and implementing projects, setting priorities and holding self and others accountable to meet commitments.
Preferred Qualifications:
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Minimum 2 Years of experience in Safety submissions, not limited to aggregate reporting and worldwide pharmaceutical safety submissions.
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In-depth knowledge of the scientific principles of the drug development process and Product registration (Pharma & Medical devices).
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In-depth knowledge of regulations pertaining to pharmacovigilance, drug product labeling and experience
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Excellent oral and written communication skills and attention to details
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Good project management skills and Effective critical thinking skills.
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Being proactive, active involvement, process ownership and responsibility.
Key Requirements/Minimum Qualifications:
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Bachelor’s Degree or Equivalent years of directly related experience (or high school +10 yrs; Assoc.+6 yrs; M.S.+0 yrs)
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The ability to fluently read, write, understand, and communicate in English.
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2 Years of Relevant Experience
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Work hours: 40 hours, standard M-F
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Travel Requirements: 0-5%
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Relocation assistance: No
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Sponsorship available: No
Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.
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