Pfizer, a global leader in the pharmaceutical industry, is seeking an experienced professional to join their team as an Associate – Aggregate Report Coordinator in Chennai, India. This full-time position plays a crucial role in managing safety aggregate reports for regulatory submissions to authorities such as the FDA and EMA. If you have a passion for clinical research, project management, and regulatory compliance, this opportunity might be the perfect fit for you.
Pfizer, one of the world’s premier biopharmaceutical companies, is committed to bringing innovative therapies to patients across the globe. With a focus on advancing wellness, prevention, treatments, and cures, Pfizer operates in over 175 markets. The company’s dedication to scientific excellence and strong ethical values ensures that they remain at the forefront of the pharmaceutical industry, making a positive impact on millions of lives.
Responsibilities in the Job
As an Associate – Aggregate Report Coordinator at Pfizer, your primary responsibility will be to manage the project lifecycle of safety aggregate reports submitted to regulatory authorities. You will collaborate closely with colleagues from various departments, including Safety, Clinical, Regulatory, and others, to compile and submit these critical reports. Key responsibilities include:
- Leading Report Preparation: Coordinate the entire process from preparation to submission, working with key stakeholders in Clinical, Regulatory, Safety, DevOps, and Submissions.
- Data Review: Ensure consistency and accuracy of data provided by different contributors.
- Report Compilation: Use various electronic tools and document management systems to gather information and compile reports.
- Review and Approval Coordination: Manage the review and approval process, addressing any comments or feedback received.
- Regulatory Compliance: Ensure all reports are completed and submitted before regulatory due dates.
- Guidance and Support: Provide contributors with guidance on report requirements.
- Project Participation: Engage in subject matter tasks and projects that support group deliverables.
- User Acceptance Testing (UAT): Participate in developing and performing UAT as needed.
- Training Compliance: Complete required training according to Pfizer’s and WSR Safety Information Management curriculum.
Qualifications
To be considered for this role, candidates must meet the following qualifications:
- Educational Background: Bachelor’s Degree in life sciences, healthcare, or pharmaceutical discipline.
- Communication Skills: Excellent English verbal, written communication, and presentation skills.
- Attention to Detail: Must be detail-oriented and capable of managing multiple tasks.
- Project Management: Strong project management and issue resolution skills.
- Regulatory Knowledge: Understanding of regulatory and safety regulations and guidelines is desired.
- Technical Skills: Proficiency in Microsoft Word & Excel, Adobe Acrobat, ISI Toolbox, and SharePoint technology. Experience with Business Objects is a plus.
Skills
Candidates applying for the Associate – Aggregate Report Coordinator position should possess a combination of technical and soft skills:
- Technical Proficiency: Familiarity with tools like Microsoft Word, Excel, Adobe Acrobat, ISI Toolbox, and SharePoint technologies.
- Project Management: Ability to lead and manage projects efficiently, ensuring deadlines are met.
- Cross-functional Collaboration: Demonstrated ability to work effectively in a cross-functional environment.
- Attention to Detail: A meticulous approach to ensuring data consistency and accuracy.
How to Apply
If you’re ready to take the next step in your career and join a dynamic team at Pfizer, you can apply for the Associate – Aggregate Report Coordinator position in Chennai by visiting Pfizer’s official careers page. Ensure your resume highlights your relevant experience, skills, and qualifications. Pfizer is an equal opportunity employer, committed to providing a diverse and inclusive workplace.
