Pfizer, a global leader in pharmaceuticals, is renowned for its innovation in developing medicines and vaccines that benefit people worldwide. The company’s Safety Surveillance division plays a key role in monitoring the safety of Pfizer’s product portfolio, ensuring that regulatory compliance and safety standards are met. The role of a Senior Safety Surveillance Associate is pivotal in maintaining the highest safety standards in clinical and post-marketing settings.
Primary Responsibilities As a Senior Safety Surveillance Associate, your main tasks will include:
- Identifying and selecting routine cases for processing, prioritizing them, and documenting reasons for delays.
- Assessing and escalating complex cases appropriately.
- Reviewing and processing event terms, classifications, product complaint information, and reportability.
- Writing and editing case narratives while ensuring adherence to regulatory compliance timelines.
- Generating safety reports and determining necessary case follow-ups.
- Collaborating with Pfizer Country Organizations, Clinical Development teams, and License Partners to ensure proper safety data collection and reconciliation.
- Developing expertise on Pfizer’s product portfolio, corporate regulations, global guidelines, and Standard Operating Procedures.
- Consistently applying regulatory requirements and Pfizer policies throughout your work.
Technical Skill Requirements To excel in this position, the following skills and experiences are preferred:
- Experience in pharmacovigilance, clinical care, or clinical/scientific research.
- Proficiency in using and managing relational databases.
- Ability to meet performance standards and achieve personal objectives.
- Strong oral and written communication skills.
- Fluency in English is required, with additional language proficiency considered a plus.
- Experience in medical writing is advantageous.
Qualifications To be considered for this role, candidates should possess the following qualifications:
- A degree in a healthcare-related field, such as Pharmacy, Dentistry, or Nursing.
- 0-6 years of relevant experience in pharmacovigilance or a related field.
- The ability to work under supervision in a matrix organization.
