[Hiring] Safety & PV Coordinator II @Syneos Health

Role Description

This role involves assisting with safety, pharmacovigilance and regulatory activities including:

• 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
• Adhering to all 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
• Processing of information may include filtering, cleansing, migrating, analyzing, reporting, filing or publication of data and information

Company Description

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Over the past 5 years, we have worked with:

• 94% of all Novel FDA Approved Drugs
• 95% of EMA Authorized Products
• Over 200 Studies across 73,000 Sites and 675,000+ Trial patients

We are 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.

We are committed to our Total Self culture – where you can authentically be yourself.