Senior Associate - Aggregate Report Analyst

Requirements

• Bachelor's Degree in life sciences and 2+ years' relevant medical experience such as, patient care, clinical trial experience / investigator, academic medicine, specialty training or pharmaceutical industry experience, ideally in safety, regulatory or clinical areas.
• Language skills. High fluency in written English and strong functional fluency in spoken English. Knowledge of additional languages is an asset.
• Writing skills. Excellent scientific writing skills, including an ability to summarize and interpret complicated data effectively, concisely and persuasively.
• Analytic skills. Ability to examine data, formulate reasonable hypotheses, and design and execute analyses to test them.
• Regulatory knowledge. Familiarity with global regulatory guidance (especially ICH, FDA and EMA) relevant to clinical and safety data.
• Makes decisions that require choosing between multiple options to resolve moderately complex problems in standard situations.
• Furthermore, you are a self-motivated person with strong organiz

Benefits

Additional Information

Pfizer is looking for a motivated Aggregate Report Analyst with international mindset to join the Worldwide Safety department - Site of Chennai. Why Patients Need You Pfizer Worldwide Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. The Aggregate Report Analyst is responsible for creation of documents to support product development, license application, and post-marketing maintenance. The Aggregate Report Analyst accurately translates regulatory requirements and corporate policies governing documents for regulatory submission into execution of timely and compliant analyses and presentations of safety data and benefit-risk assessment in documents, empowering healthcare decisions regarding the safe and appropriate use of medicines for patients. Key Experience Offer of this Role You will be placed in an international environment and interact with colleagues from different sites, mainly in Europe, United States and Asia, having the possibility to expand your professional network. You will have the opportunity to: Be a member of Aggregate Report Center of Excellence team, collaborating with experienced colleagues across the globe. Liaise with key partners, including Safety lines, QPPV, Regulatory, Medical, Clinical, Epidemiology, License Partners, and other stakeholders regarding preparation of documents and communication of benefit-risk assessment. Collaborate with quality lines and relevant project team subject matter experts, ensuring the accuracy and quality of information presented in assigned documents. If assigned by manager, serve as the Worldwide Safety 'point of contact' for all document issues for a given product or set of products. Identify potential areas for process improvements and possible solutions, and communicate these to line management or appropriate functional line. We are happy to offer you: International team of junior/senior colleagues In-depth training/mentoring process Dynamic environment Growth potential Primary Responsibilities You will follow standard procedures to support and complete tasks, some of which may vary in scope, sequence, complexity and timing, requiring flexibility and multitasking skills but you will also contribute to the team's success by sharing your enthusiasm, collaboration and your previously acquired knowledge. Your main responsibilities will focus on: Preparing integrated analyses of safety data in support of aggregate reports (e.g., Development Safety Update Reports, Periodic Safety Update Reports, Period Benefit Risk Evaluation Reports, Addendum to Clinical Overviews, New Drug Application Periodic Adverse Drug Experience Reports, etc.), responses to regulatory queries on safety topics, post-marketing safety assessments, and Risk Management Plans and relevant documents. Communicating Worldwide Safety department's position on resource and timeline needs for assigned documents to project team members, negotiating as needed with the team on these matters and keeping line management informed. Ensuring assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams and line management in a timely manner of any definite or potential deviations. Delivering assigned documents on or before deadline. Driving the document strategies and messages in a collaborative way with relevant project team subject matter experts. Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents. Providing oversight for internal or external (contractor) co-authors when required for a particular project or assignment. Understanding relationships and dependencies between documents and analyses produced for regulators across the development of RMPs, DSURs, PBRERs, and ACOs. What You Offer

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