Process Analyst

Process Analyst

Use your power for purpose. Our mission is straightforward: empower healthcare decisions regarding the safe and appropriate use of medicines for patients. Whether you are developing the framework to ensure our evidence is scientifically robust, providing unbiased and medically essential expertise, or exploring ways to bridge data gaps, your role is vital. By ensuring our evidence is sound and offering necessary medical insights, we strive to improve patient care and treatment efficacy.

The Process Analyst (PA) will be responsible for managing product and non-product related projects to support the Worldwide Safety (WWS) department, primarily the Safety Surveillance and Risk Management (SSRM) Business Units (BUs), but also other groups within WWS as appropriate.

The PA will be responsible for supporting both novel and routine SSRM and Safety processes, within and across Disease Areas, Safety Lines and BUs.

The PA will be responsible for independently managing processes, compliance, and performance metrics.

What you will achieve:

In this role, you will:

• Supports Risk Management Committee (RMC) and Benefit Risk Committee (BRC) meetings. This includes, but is not limited to, ensuring that the meeting happens in line with the relevant Clincal and Medical Controlled Documents (CMCDs), ensuring the correct personnel are invited to the meeting, issuing agendas prior to the meeting, drafting and finalizing meeting minutes and ensuring actions are completed in a timely fashion. The PA at this level must have a good understanding of the relevant CMCDs to help guide the SRLs and clinical teams for their drug products.

• Signal Tracking Log monitoring duties include:
• Monitors Regulatory Authority sites for safety signals for Pfizer products
• Ensures signals are evaluated at RMC
• Monitors and reviews signals entered into the log for completeness and timeliness of completion
• Contributes to aggregate reports for products with relevant signals
• Assists with internal and external inspection preparations relating to safety and ensures timely provision of responses to inquiries raised by inspectors/auditors.

• Manages small non-drug product projects (such as process improvement initiatives, metrics monitoring, etc).
• Responsible for executing and implementing good document management practices across all supported safety activities.
• Assists the Risk Management Product Leads (RMPLs) with the tracking of additional risk minimization measures (aRMMs) in Risk Management Plans (RMPs), as appropriate.

Here is what you need (minimum requirements):

• Effective analytical skills - detail oriented, independent, and manages processes to both establish timelines and ensures timelines are met. Good organizational skills.
• Fundamental knowledge of the principles and concepts of pharmacovigilance.
• Computer applications - the PA should be competent in various computer applications as well as department systems.
• Skills in matrix partnerships to affect inclusive and collaborative working relationships with WWS colleagues, including engaging SSRM Group Heads and other colleagues supplying sources of safety information. Actively engages RMC and BRC members as needed.
• Effective verbal and written communication skills relating to colleagues and associates both inside and outside the organization.
• Working effectively when co-located with, AND when remote from, product teams/leaders/managers.
• Can handle more than one project simultaneously.
• Relevant knowledge of pharmaceutical company organizational structure, policies, and practices, as applicable to Safety Risk Management.

Bonus points if you have (preferred requirements):

• Master's degree
• Relevant pharmaceutical industry experience
• Familiarity with management of performance metrics
• Strong problem-solving skills
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use