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Safety Data Management Specialist
Pfizer
Place of work
Bratislava
Bratislava
Contract type
full-time
full-time
Wage (gross)
1 300 EUR/month1300€/month upon candidate seniority
1 300 EUR/month1300€/month upon candidate seniority
Information about the position
Job description, responsibilities and duties
For our Pfizer office in Bratislava, Slovakia we are looking for a Safety Data Management Specialist. (pharmacovigilance specialist)
MAIN REPONSIBILITIES / DUTIES:
Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer's products and to meet regulatory requirements. Determination of local submission of individual and, where appropriate, aggregate safety reports
Responsibilities
• 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 the appropriate workflow for case processing
• Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately
• Write and edit the 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
MAIN REPONSIBILITIES / DUTIES:
Review, preparation, and completion of reports of adverse drug experiences, to determine the safety profile of Pfizer's products and to meet regulatory requirements. Determination of local submission of individual and, where appropriate, aggregate safety reports
Responsibilities
• 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 the appropriate workflow for case processing
• Assess cases to distinguish those with particular complexities and/or specific issues, and escalate appropriately
• Write and edit the 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
Information about the selection process
In addition to competitive salaries and customized benefits packages, we offer a supportive and diverse culture and unparalleled career development opportunities.
Please apply in English documents only!
Please apply in English documents only!
Requirements for the employee
Candidates with education suit the position
Secondary with school-leaving examination
University education (Bachelor's degree)
University education (Master's degree)
University education (Bachelor's degree)
University education (Master's degree)
Language skills
English - Upper intermediate (B2)
Personality requirements and skills
REQUIRED SKILL SET
• Educated to university degree level (biology, biotechnology, chemistry, pharmacy, technology) or Health Care Professional experience required
• Experience in pharmacovigilance and/or data management preferred but not required
• Experience and skill with medical writing an advantage
• Experience in use and management of relational databases preferred
• Sense of responsibility
• Quality orientation
• Very good level of computer skills (advanced Excel, Word, PowerPoint)
• Ability, with supervision, to solve routine problems and to surface issues constructively
• Ability to make basic decisions with an understanding of the consequences
• Ability to work under supervision in a matrix organization
• Fluency in spoken and written English
• Educated to university degree level (biology, biotechnology, chemistry, pharmacy, technology) or Health Care Professional experience required
• Experience in pharmacovigilance and/or data management preferred but not required
• Experience and skill with medical writing an advantage
• Experience in use and management of relational databases preferred
• Sense of responsibility
• Quality orientation
• Very good level of computer skills (advanced Excel, Word, PowerPoint)
• Ability, with supervision, to solve routine problems and to surface issues constructively
• Ability to make basic decisions with an understanding of the consequences
• Ability to work under supervision in a matrix organization
• Fluency in spoken and written English
Advertiser
Brief description of the company
Breakthroughs That Change Patients' Lives: Pfizer is a leading research-based biopharmaceutical company. We apply science and our global resources to deliver innovative therapies that extend and significantly improve lives. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time.To learn more, visit www.pfizer.com.
ID: 3692446
Posting date: 12.6.2019
2019-06-12
location: Bratislava Position: Medical/Pharmaceutical Sales Representative, Pharmacist, Regulatory Affairs Specialist Company: Pfizer
Basic wage component (gross) and other rewards: 1 300 EUR/month1300€/month upon candidate seniority