Lead team tasked with oversight of all Risk Management Operations, data management and
associated quality control. Contact point for country offices (PCO's) for issues related to risk
management operations, interface with Head of Risk Management Center of Excellence and
other Worldwide Safety staff and leadership.
Primary Responsibilities Include:
Lead team of Risk Management Operations colleagues
Data Entry, quality control, and maintenance of additional risk minimization measures and risk management commitments into the global RMP management tool (COMPASS)
Collaborate with other colleagues involved in Risk Management Oversight including (but not limited to) Risk Management Product Leads (RMPL), Safety Risk Lead (SRL), RMP Authors,
Qualified Persons for Pharmacovigilance (QPPV), Country Safety Leads (CSL's), etc.
Support all relevant audits and inspections
Maintain expertise in relevant worldwide regulations and guidelines
Promote increased awareness of the legislative and regulatory environment in the countries
Develop and maintain knowledge of applicable SOPs and other procedural documentation
Provide guidance for standardization of processes and goals
Manage and monitor the effective rollout of new processes
Facilitate resolution of concerns and questions
Mentor colleagues on the effective use of the global risk management tool (COMPASS)
Support the organization and management of inspection readiness activities
Support implementation of corrective actions resulting from timeliness or quality issues associated with risk management-related activities
Responsible for the effective Leadership of an engaged team of colleagues performing in an appropriate work environment and for the related training and development, performance management, succession planning, and human resources processes while ensuring compliance with required regulations and practices.
-Develop a culture of courage, excellence, equity and joy within the team including coaching
and mentoring the team as required
Technical Skill Requirements:
Good understanding of medical and scientific terminology
Knowledge of risk management operations, regulations and processes
Rational approach to issues and their business implications
Good problem solving and decision making skills
Team building and team management skills
Strong interpersonal skills, with a demonstrated ability to manage people and foster teamwork
Excellent communication and negotiation skills
Good oral and written communication
Highly skilled in time management and change management, organizational and facilitation skills
Ability to meet personal objectives while meeting departmental standards of performance
Qualifications:
Bachelor's degree in a science-related field, pharmacy or nursing or equivalent, advanced degree an advantage
Minimum of four years research, clinical or equivalent experience in the pharmaceutical industry;
1-2 yrs managerial experience in industry, hospital or pharmacy, familiar with clinical
Good understanding of computer technology, and management of relational database systems
1+ years of experience in people management required
Minimum 5 years experience in pharmacovigilance and/or data management, clinical care, or clinical or scientific research required
Demonstrated computer literacy, particularly in the use and management of relational
databases
Excellent knowledge of national and international regulations
Excellent oral and written communication skills
Fluency in spoken and written English
#LI-PFE
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
#LI-PFE
Pfizer
associated quality control. Contact point for country offices (PCO's) for issues related to risk
management operations, interface with Head of Risk Management Center of Excellence and
other Worldwide Safety staff and leadership.
Primary Responsibilities Include:
Lead team of Risk Management Operations colleagues
Data Entry, quality control, and maintenance of additional risk minimization measures and risk management commitments into the global RMP management tool (COMPASS)
Collaborate with other colleagues involved in Risk Management Oversight including (but not limited to) Risk Management Product Leads (RMPL), Safety Risk Lead (SRL), RMP Authors,
Qualified Persons for Pharmacovigilance (QPPV), Country Safety Leads (CSL's), etc.
Support all relevant audits and inspections
Maintain expertise in relevant worldwide regulations and guidelines
Promote increased awareness of the legislative and regulatory environment in the countries
Develop and maintain knowledge of applicable SOPs and other procedural documentation
Provide guidance for standardization of processes and goals
Manage and monitor the effective rollout of new processes
Facilitate resolution of concerns and questions
Mentor colleagues on the effective use of the global risk management tool (COMPASS)
Support the organization and management of inspection readiness activities
Support implementation of corrective actions resulting from timeliness or quality issues associated with risk management-related activities
Responsible for the effective Leadership of an engaged team of colleagues performing in an appropriate work environment and for the related training and development, performance management, succession planning, and human resources processes while ensuring compliance with required regulations and practices.
-Develop a culture of courage, excellence, equity and joy within the team including coaching
and mentoring the team as required
Technical Skill Requirements:
Good understanding of medical and scientific terminology
Knowledge of risk management operations, regulations and processes
Rational approach to issues and their business implications
Good problem solving and decision making skills
Team building and team management skills
Strong interpersonal skills, with a demonstrated ability to manage people and foster teamwork
Excellent communication and negotiation skills
Good oral and written communication
Highly skilled in time management and change management, organizational and facilitation skills
Ability to meet personal objectives while meeting departmental standards of performance
Qualifications:
Bachelor's degree in a science-related field, pharmacy or nursing or equivalent, advanced degree an advantage
Minimum of four years research, clinical or equivalent experience in the pharmaceutical industry;
1-2 yrs managerial experience in industry, hospital or pharmacy, familiar with clinical
Good understanding of computer technology, and management of relational database systems
1+ years of experience in people management required
Minimum 5 years experience in pharmacovigilance and/or data management, clinical care, or clinical or scientific research required
Demonstrated computer literacy, particularly in the use and management of relational
databases
Excellent knowledge of national and international regulations
Excellent oral and written communication skills
Fluency in spoken and written English
#LI-PFE
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
#LI-PFE
Pfizer
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Makati City, Metro Manila
Permanent
Full-time
Permanent
Full-time
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Pfizer
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