Pharma Compliance Manager Job Vacancy @ Pfizer
Pharma Compliance Manager Job. Manager Post. Pharma Manager Job. Manager Post vacant @ Pfizer. Pfizer 2019 Jobs, Pfizer Medical jobs, Pharmaceutical Science jobs 2019. Pfizer hiring M Pharma candidates Pharmacy vacancy. Interested and eligible candidate can apply for this post. Check out all the details on the same below:
Job Title: Manager
A scientific or technical degree is preferred. In general, candidates for this job would have the following levels of education/experience:BS degree (or equivalent).
- 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.
Manages projects and conducts QC activities on deliverables produced by SER, SSRM, Epi and CD&O ensuring accuracy, internal consistency, uniformity and compliance with regulatory commitments and expectations.
- Provides leadership to ongoing analysis of data resulting from the quality review of regulatory submission documents/aggregate reports.
- Collaborates with SER authors, epidemiologists, SSRM 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.
- Provides mentoring and training for colleagues as necessary, working with Team Leads to provide support across all sites.
- Compiles and analyzes quality metrics on a routine basis, and periodically reports trends relating to document quality review.
- 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.
- 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 quality Subject Matter Expert (SME) 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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