Aggregate Report Management Scheduling Lead (Pharmacovigilance)
Job Description
Position Purpose
Oversees all aspects of creating, maintaining and implementing a comprehensive, dynamic and resource efficient calendar of safety aggregate report deliverables. This includes, but is not limited to IND ARs, DSURs, PADERs, PAERs, PSURs and SUSAR LLs. This position negotiates safety submission commitments with Pfizer Country Offices and/or Regulatory, ensuring compliance needs are met while balancing resource effort to create submission documents; interacts with requestors to resolve ad hoc report scheduling; and proposes assignments.
Primary Responsibilities
Creates and maintains the comprehensive safety aggregate report calendar.
Enters and assigns scheduled, and non-scheduled safety aggregate report deliverables.
Negotiates with appropriate groups (e.g., PCOs) to ensure that aggregate report commitments are met, while minimizing, the number of individual reports required, when possible, as well as developing schedules for new aggregate report types as required by regulations.
Participates in appropriate governance and policy meetings/groups. Is empowered to make independent decisions affecting the operations of the group.
Acts as subject matter expert on aggregate reports scheduling and represents this role on various teams and taskforces.
Acts as business subject matter expert for systems used for aggregate reports calendar (DocFlow) and the RMP assignment (Content Management and Process Automation Solutions – COMPASS) and participates in various technology forums.
Design, implement, and report relevant aggregate reporting metrics.
Supports Audit/inspection requests.
Monitors License Partner aggregate report request and Aggregate Reports ad hoc mailbox.
Technical Skill Requirements
Demonstrated ability to lead/manage and bring projects to successful completion while simultaneously juggling multiple projects and processes that span globally.
General knowledge/understanding of technologies that can support Pfizer’s safety submission work. Ability to adequately evaluate and leverage Pfizer’s system into improved business processes to support business requirements.
Comprehensive working knowledge of requirement gathering, database design, and reporting.
Knowledge of clinical development and/or regulatory submission processes and requirements. Knowledge of safety submission work, e.g., aggregate reporting requirements and processes.
Effective oral and written communication.
Demonstrated ability to design, develop and deliver effective presentations to key business units.
Qualifications
Minimum Bachelor’s degree with scientific/technical academic background or equivalent, ideally with experience in the pharmaceutical industry, regulatory agency, or related field.
Understanding of safety and global regulatory reporting regulations and guidelines
Knowledge of clinical trials and drug development as well as comprehensive knowledge of the regulatory environment.
Strong project management skills with appropriate follow-through
Develop and run relevant aggregate reporting metrics and/or reports.
Preforms scheduling lead responsibilities with guidance.
Comprehensive working knowledge and understanding of IT requirement gathering, database structure, design and reporting tools.
Demonstrated ability to manage projects successfully, with minimal guidance.
Participates in appropriate governance and policy meetings/groups.
Work Location Assignment: Warsaw Site, hybrid work.
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Apply Now
Please mention to the employer that you saw this ad on Sciencejobs.org
- Share this job:
- [Save this Job]
