1 300 EUR

Safety Data Management Specialist

Pfizer

Place of work
Bratislava
Contract type
full-time
Total wage (gross)
1 300 EUR

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

Basic wage component (gross) and other rewards

1300€/month upon candidate seniority

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!

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)

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

Advertiser

Brief description of the company

All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talents who share our core values and mission of making the world a healthier place.

Company address

Pfizer
-
- -

Contact

E-mail: send CV
ID: 3692446   Dátum zverejnenia: 12.6.2019   Základná zložka mzdy (brutto) a ďalšie odmeny:   1300€/month upon candidate seniority