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Safety data management specialist
PFIZER LUXEMBOURG SARL, organizačná zložka
Place of work
Pribinova 25, Bratislava
Pribinova 25, Bratislava
Contract type
full-time
full-time
Start date
1.6.2014
1.6.2014
Wage (gross)
upon agreement
upon agreement
Information about the position
Job description, responsibilities and duties
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
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
Requirements for the employee
Candidates with education suit the position
University education (Bachelor's degree)
University education (Master's degree)
Postgraduate (Doctorate)
University education (Master's degree)
Postgraduate (Doctorate)
Educational Specialization
biology, biotechnology, chemistry, pharmacy, biotechnology
Language skills
English - Upper intermediate (B2)
Other knowledge
Microsoft Excel - Advanced
Microsoft Word - Advanced
Microsoft Outlook - Advanced
Microsoft Access - Advanced
Microsoft Word - Advanced
Microsoft Outlook - Advanced
Microsoft Access - Advanced
Driving licence
B
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
Reports to: Country Safety Lead
Location: TOWER 115, Pribinova 25, Bratislava
Effective date: May - June 2014
• 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
Reports to: Country Safety Lead
Location: TOWER 115, Pribinova 25, Bratislava
Effective date: May - June 2014
Advertiser
Brief description of the company
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Number of employees
50-99 employees
ID: 1684033
Dátum zverejnenia: 4.4.2014
2014-04-04
lokalita: Bratislava Pozícia: Administrative Worker, Official, Archivist, Registry Administrator, Drug Safety Specialist, Medical/Pharmaceutical Sales Representative, Pharmacist Spoločnosť: PFIZER LUXEMBOURG SARL, organizačná zložka
Základná zložka mzdy (brutto) a ďalšie odmeny: upon agreement