Pharma Compliance Manager Job Vacancy @ Pfizer

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

Education:

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).

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.

Position Purpose

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.

Primary Responsibilities

  • 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.
See Also
MSc Chemistry Application Specialist Job @ Bruker

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.

Apply Online

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