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Safety & PV Specialist I - Data Management

Location

Bulgaria

Posted

17 days ago

Salary

0

Seniority

Mid Level

Job Description

Safety & PV Specialist I - Data Management

Syneos Health

Role Description Assists with safety, pharmacovigilance and regulatory activities including (but not limited to): - Medical Dictionary for Regulatory Activities (MedDRA) coding - Data management activities which includes cleaning and validation of data - xEVMPD product dictionary - Substances, Products, Organizations and Referential (SPOR) / Identification of Medicinal Products (IDMP) data cleansing - Data mapping, data enrichment and data validation activities All activities must adhere to: - Data privacy guidelines - Good Clinical Practice (GCP) - Good Pharmacovigilance Practice (GVP) - Regulatory guidelines - Company and project/program-specific procedures for clinical trials and/or post-marketing safety programs The processing of information may include: - Filtering - Cleansing - Migrating - Analyzing - Reporting - Filing or publication of data and information Qualifications - Bachelor’s degree in scientific field (Life Sciences degree) - 2+ years in scientific/clinical research background with experience in Data handling/Data validation/Regulatory processes - English fluency to collaborate with regional and global teams Requirements - Review existing system data against reference sources - Identify discrepancies and update records per project regulatory guidelines - Analyze data based on BU reference standards - Focus on accurate processing and maintenance of structured data - Update incomplete fields - Create or submit missing information - General data entry and quality improvement Benefits - Passionate about developing our people through career development and progression - Supportive and engaged line management - Technical and therapeutic area training - Peer recognition and total rewards program - Commitment to building an inclusive culture

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