Aggregate Reports Analyst Job in Chennai at Pfizer

Pfizer is hiring for the position of Aggregate Reports Analyst!

Responsibilities of Candidate:

• 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 the 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 the 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.

Requirements

• 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.