Safety Data Management Job at Pfizer
Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidence-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.
Pfizer invites vacancy position for Safety Data Management Job suitable candidate can apply for this position online.
You will be relied on by the company to monitor its drug, biologics, and medical devices surveillance program. This will include intake, evaluation, and processing of the adverse reports received. You will support the clinical trial as well as post-marketing activities.
As an associate, your focus on the job will contribute to achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.
It is your dedication and hard work that will make it possible for Pfizer’s customers and patients to receive the medicines they need when they need them.
Post: Safety Data Management Job
How You Will Achieve It
- Carry out case processing activities
- Review, rank, verify, process and document case-related information: event terms; validity, seriousness, special scenarios; timelines; accuracy and consistency. Process cases based on these assessments
- Review case criteria to determine appropriate workflow for case processing
- Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately
- Write and edit case narrative
- Determine and perform appropriate case follow-up, including generation of follow-up requests
- Review processed cases to verify accuracy, consistency and compliance with process requirements, and review case data for special scenarios
- Liaise with key partners, locally , and other stakeholders regarding safety data collection and data reconciliation
- Develop and maintain expertise and knowledge for applicable corporate and global regulations, for guidelines, Standard Operating Procedures, for data entry conventions, and for search functions in the safety database
- Determine reportability of scheduled reports, ensuring adherence to regulatory requirements
- Consistently apply regulatory requirements and Pfizer policies
- Participate, as appropriate, in local, internal and external safety activities
- Only BDS/BPT/Nursing/B. Pharm/M. Pharm/Pharm. D/para-medical graduate qualifications.
- Work experience in Pharmacovigilance, ICSR (Individual Case Safety Reports) processing (minimum exp = 6 months, maximum exp = 3 years).
- Sound PV knowledge, proven analytical skills with attention to detail.
- ARGUS safety database and E2B processing experience.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.