This role collaborates across business units and functional lines and has accountability to ensuring that Investigator’s Brochures (IBs) are created, revised, maintained, and submitted in compliance with governing SOPs and regulatory requirements. The RSD Lead is an extended study team member responsible for ensuring the release of all Single Reference Safety Documents (SRSDs) (both IB and non-IB) for submission to regulators, to share the known risks of medicinal products under study for all Pfizer-sponsored protocols, and for their use as the Reference Safety Information (RSI) for expectedness assessments by Pfizer’s drug safety analysts.

The role will be accountable for contributing to relevant initiatives, including continuous improvement projects and technology advances to ensure effective management and delivery of all reference safety documents used in clinical trials. The role will report to the Reference Safety Document Management Head.
 

Provide overall management of the creation and maintenance of Investigator Brochures, by

• Chairing IB meetings, leading team discussions utilizing subject matter and regulation expertise to establish appropriate strategy for the IB.

• Providing end-to-end project management of the IB deliverable, setting clear targets and ensuring all functional lines are aware of commitments, securing necessary contributions, and completing within agreed timelines.   

• Ensuring full execution of all IB documents (initial creation and updates) in compliance with ICH guidance, regulations and internal policies. 

• Interpreting and advising current regulations/guidance considering the wide range of needs of various internal stakeholders.

• Identifying risks and leading IB contributing teams through issues and barriers to achieve timely and quality resolution.

Managing Single Reference Safety Documents (SRSDs) associated with clinical trials by:

• Monitoring for updates to their Reference Safety Information (RSI)

• Obtaining appropriate authorizations from key regulatory and safety contributors

• Maintaining appropriate versions and make availability by drug safety teams, and

• Communicating all updates to clinical investigators

Contribute to the broader needs of the Reference Safety Document Management team by:

• Serving as a subject matter expert for products within their scope of remit

• Understanding roles, responsibilities and dependencies of upstream and downstream stakeholders and deliverables.

• Acting as a subject matter expert for quality events, contributing to the investigation/root cause analysis and remediation actions as appropriate. 

• Providing training and mentoring to new colleagues and any contractors/vendors involved in the process.

• Proactively evaluating current systems and processes and offering suggestions for improvements.

• Assessing external regulatory requirements, ICH guidance and performing initial impact assessment when requested.  

• Ensure all actions taken within role follow applicable policies, SOPs and associated documents so that high quality delivery of outputs and compliance is maintained.

Qualifications, skills and experience

Education:

Life sciences, pharmacy graduate or equivalent. Advanced academic qualifications/degree an advantage.

Experience & Attributes

Extensive pharmaceutical regulatory experience; labelling experience preferable:

• Pharmaceutical experience associated with content development and maintenance within the area of Regulatory Affairs, Drug Safety, or Medical Affairs

• Understanding of the dynamics and purpose of a company Investigators Brochure and core function of SRSD management is highly desirable. 

• Knowledge of overall drug development process and experience with regulated deliverables. 

• Basic Pharmacovigilance knowledge desirable.

• Proven ability to understand regulatory implications on strategy for product deliverables.

• Knowledge of ICH, CIOMS and key markets regulations and requirements.

Technical Skills

• Proven leadership in leading global teams through consistent execution and delivery. 

• Demonstrated ability to build and foster strong matrix team working relationships across global setting.

• Strong project management skills with a focus on quality and compliance. Skilled in managing and delivering multiple projects on time despite competing priorities and conflicts.

• Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy.  Demonstrated ability to influence and negotiate despite having a wide and diverse set of stakeholders.

• Ability to interpret and apply global and local regulatory requirements and guidance to business needs, in both pre and post approval products. 

• Proven ability to make sound decisions and seek to resolve problems in a proactive, independent manner.  

• Proven excellence in effective written and oral communication. 

• An understanding of medical terminology.   

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.

DisAbility Confident

We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!