Pharmacovigilance Aggregate Safety Reporting Author

Peapack, New Jersey
February 21 2021
Position Type
Full Time
Organization Type
Why Patients Need You
Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

What You Will Achieve

Your strong documentation skills will be an asset for the team. You will help us draft manuscripts on clinical studies and scientific reports for submission to regulatory agencies or in-company use. You will also help with summaries, monographs, comprehensive reviews, scientific exhibits and projects requiring skill in medical communication.

Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams.

It is your problem solving ability that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It
  • Provide guidance, lead/co-lead projects, manage own time to meet objectives, plan resource requirements for projects across the division.
  • Drive document strategies and messages in a collaborative way with relevant project team subject matter experts.
  • Ensure documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in agreed document management system.
  • Verify accuracy of document content using source documents including clinical regulatory documents and data tables, figures, and listings.
  • Ensure that medical writing deliverables conform to International Conference on Harmonization and other relevant regulatory guidelines.
  • Lead a team of internal or external authors if multiple or complex documents are required for a particular project.
  • Understand relationships and dependencies between documents and analyses produced for regulators.
  • Independently perform Quality Control (QC) review and manage QC projects in accordance with agreed upon timelines.
  • Contribute to the training of colleagues on quality standards and processes.
  • Develop and sustain constructive relationships within other Pfizer lines including country organizations.
  • Record findings and identify appropriate corrections to address findings.


  • 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
  • Experience in interacting with cross functional study team members
  • Solid understanding of medical terminology and clinical trials
  • Excellent interpersonal and communication skills
  • Ability to plan, organize, prioritize, and execute multiple tasks within assigned objectives
  • Proficiency with computer applications (MS Office)

  • Advanced degree preferred (MD, DVM, PharmD, or Master's/PhD in relevant field)
  • Experience with software commonly used to present and analyze data

Other Job Details:
  • Last Date to Apply for Job: February 26, 2021
  • Eligible for Employee Referral Bonus: YES

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.


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