Pfizer, a global leader in biopharmaceuticals, is renowned for its commitment to improving health through innovative research, cutting-edge technology, and high-quality product delivery. With a vast portfolio of medicines and vaccines, Pfizer’s global network includes collaborations with healthcare providers and regulatory bodies to uphold the highest standards in patient safety. The Safety Surveillance Associate position is pivotal to maintaining these standards through vigilant safety monitoring and regulatory compliance.
Job Overview
Location: India – Chennai
Job Type: Full-time
Reports To: Case Processing Team Lead
Job Requisition ID: 4923670
Position Purpose
The Safety Surveillance Associate is responsible for reviewing, preparing, and completing adverse drug experience reports to assess the safety profile of Pfizer’s products and meet regulatory obligations. This role plays a critical part in Pfizer’s pharmacovigilance efforts to ensure that product safety data is consistently monitored and analyzed.
Primary Responsibilities
- Case Selection and Prioritization: Identify and select routine cases for processing, ensuring correct prioritization and documenting any reasons for delays.
- Case Assessment and Escalation: Evaluate cases to determine complexities or special issues, escalating as needed.
- Documentation and Processing:
- Verify and document event terms, case classifications (validity, seriousness, expectedness/listedness/labeledness), special scenarios, and reportability.
- Prepare case narratives and ensure reports adhere to compliance timelines.
- Workflow Management: Determine appropriate workflow for processing each case.
- Report Generation: Create reports while meeting regulatory compliance timelines.
- Case Follow-Up: Decide on necessary case follow-ups and request follow-up communications.
- Collaboration: Work with Pfizer Country Organizations, Clinical Development, and License Partners for safety data collection and reconciliation.
- Product Expertise: Develop in-depth knowledge of Pfizer’s product portfolio, corporate and global regulations, Standard Operating Procedures (SOPs), and writing practices.
- Compliance: Ensure that all work adheres to Pfizer’s policies and relevant regulatory requirements.
Technical Skills and Requirements
- Experience:
- Background in pharmacovigilance, clinical care, clinical research, or scientific research is advantageous but not mandatory.
- Technical Proficiency:
- Demonstrated computer literacy with experience in relational databases.
- Communication Skills:
- Strong oral and written communication in English; additional language proficiency is a plus.
- Experience with medical writing is beneficial.
- Work Environment:
- Ability to work effectively under supervision in a collaborative, matrix-based organizational structure.
- Personal and Professional Attributes:
- Ability to meet personal and departmental performance standards.
- Critical thinking and strong decision-making skills.
Qualifications
- Education: Minimum of a bachelor’s degree in a healthcare-related field such as dentistry, pharmacy, nursing, or an equivalent discipline.
- Experience: 0-4 years in pharmacovigilance, clinical research, hospital practice, or teaching.