Require Aggregate Reports Analyst at Pfizer

Founded in 1849, Pfizer is the worlds premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.

Post : Aggregate Reports Analyst

Job Description :
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.

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.

Primary Responsibilities
• 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.

Candidate Profile
• Bachelor's Degree in life sciences and 3+ 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.

Preferred Qualifications
• Advanced degree preferred (MD, DVM, PharmD, or Master’s/PhD in relevant field).
• Previous experience with software commonly used to present and analyze data (Word, PowerPoint, Excel) is preferred.
• Proficiency with statistical concepts and ability to carry out statistical analyses is desirable.
• Extensive familiarity with epidemiologic principles and concepts is desirable.

Additional Information
Qualification : Bachelor's Degree in life sciences
Location : Chennai
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 10th November, 2023