Pfizer Drug Safety Associate Vacancy 2020 – Apply Online
Pfizer Vacancies – Pharma Vacancy. MPharma candidates are eligible to apply online for a Safety Data Management Specialist – Pfizer Drug Safety Associate Vacancy 2020 – Apply Online vacancy at Pfizer. Pharma job opening 2020. Pharma job opening 2020. Check out all the details on our website Rasayanika.com
Job Title: Safety Data Management Specialist (Drug Safety Associate)
Location: India – Chennai
Qualifications
Must-Have
- 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.
- Nice-to-Have
- ARGUS safety database and E2B processing experience.
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
What You Will Achieve
- 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 the post-marketing activities.
- As an associate, your focus on the job will contribute in 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.
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