Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
Post: Safety and Regulatory Quality Analyst
Position Purpose:
Manages projects and conducts QC activities on deliverables produced by SER, SSRM, Epi, GLM, and GCTE ensuring accuracy, internal consistency, uniformity and compliance with regulatory commitments and expectations.
Primary Responsibilities
- Provides ongoing analysis of data resulting from the quality review of regulatory submission documents/ICSRs/aggregate reports produced by SER, SSRM, Epi, GLM and GCTE.
- Collaborates with SER authors, epidemiologists, SSRM, GCTE, GLM and others to develop strategies for the creation and collection of metrics data for quality analysis.
- Participates on project teams, task forces and/or working groups to identify opportunities for strategic alignment of quality and compliance processes and process improvement initiatives. - Actively participates in the investment and strategy decisions related to the technology decisions related to quality.
- Supports/promotes accuracy, internal consistency, uniformity and compliance with regulatory commitments and expectations.
- Maintains knowledge of global regulatory requirements relative to pharmacovigilance, regulatory submission requirements, electronic reporting requirements and other relevant regulatory requirements and guidances.
- Provides support for regulatory inspections, internal audits and/or strategic quality initiatives. - Manages special projects and senior management requests associated with safety compliance.
- Develops and maintains an understanding of ARGUS, Pfast and case processing activities so as to ensure the accuracy of ICSRs, aggregate reports, ad hoc reports and analyses and safety query responses.
- Provides mentoring and training for colleagues as necessary, working with Team Leads to provide support across all sites.
- Compiles and analyzes ICSR data quality metrics on a routine basis to ensure consistency within cases and correctness of the data relative to the ARGUS Users Reference Guide (AURG), Safety Job Aids (SJAs) and regulatory expectations.
- Compiles and analyzes quality metrics on a routine basis, and periodically reports trends relating to document quality review to SER, Epi, SSRM and GCTE.
- Leads and/or participates in quality activities, setting the standard for enhanced collaboration, delivery of project commitments and customer satisfaction.
- Plans, designs and participates independently, as appropriate, in the ongoing review of processes related to the collection and analysis of safety information within SER, SSRM, Epi, GLM and GCTE.
- Manages the completion of complex tasks by applying technical skills and specialized knowledge to coordinate initial findings, conduct root cause analyses and corrective action planning with customers as necessary. - May serve as a Subject Matter Expert (SME) working with SER, SSRM, GCTE, GLM and Epi on training, knowledge sharing, technology, or specific work processes, providing advice and guidance as appropriate.
Technical Skill Requirements
- Strategic Thinking – Demonstrated ability to understand and consider competitive positioning when solving problems and making decisions.
- Clinical, Regulatory and Safety Expertise – Demonstrated knowledge of clinical research processes, safety or regulatory requirements.
- Technical Expertise – Applies technical and line knowledge of key concepts in own discipline and may act as a key technical resource within line.
- Organizational Development – Knowledge of organizational development principles and demonstrated success in developing and implementing organizational development strategies.
- Project and Process Management & Meeting Established Deadlines – Demonstrated ability to manage complex projects and cross-functional processes and to meet established deadlines.
- Presentation/Influencing/Organizational Skills – Strong platform skills evident.
- Multitasking – Demonstrated ability to effectively work on simultaneous complex projects/deliverables.
- Analytical and Statistical Skills – Demonstrated analytical and statistical skills.
- Systems Technologies – Thorough understanding of system technologies that support the business.
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Qualifications (i.e., preferred education, experience, attributes)
- BS degree (or equivalent). Experience:
- Minimum 3 years experience in clinical, safety and/or regulatory areas in the pharmaceutical/healthcare industry.
- Experience in quality control and/or quality assurance within the pharmaceutical industry preferred. - Knowledge of global safety regulations and guidelines, or equivalent.
- Demonstrated strength in analytical skills and attention to detail.
- Demonstrated strength in oral/written communication and interpersonal skills.
- Demonstrated organizational/project management skills.
- Ability to make decisions independently and resolve issues appropriately.
- Demonstrated computer literacy, particularly in the use and management of relational databases. - Innovative and strategic thinking ability.
Additional Information:
Experience: 3 yrs
Qualification: BS degree
Location: Chennai
Industry Type: Pharma
Last date: 25th July, 2016
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