Senior Safety & Pharmacovigilance Operations Specialist – Regulatory Intelligence (SPVG)
Updated: February 4, 2026
Location: Belgrade, Serbia
Job ID: 25105286-OTHLOC-3256
Employment Type: Full-time
About Syneos Health
Syneos Health® is a fully integrated global biopharmaceutical solutions organization focused on accelerating customer success. By combining clinical development, medical affairs, and commercial expertise, Syneos Health supports the delivery of innovative therapies that address today’s complex healthcare challenges.
With more than 29,000 professionals across 110 countries, Syneos Health partners with biopharmaceutical companies to advance clinical research and post-marketing safety while maintaining the highest regulatory and quality standards.
Position Overview
The Senior Safety & Pharmacovigilance Operations Specialist – Regulatory Intelligence (SPVG) supports global pharmacovigilance activities by monitoring, assessing, and maintaining worldwide safety regulatory requirements. This role serves as a subject matter expert in pharmacovigilance regulatory intelligence, ensuring timely identification of regulatory changes and accurate impact assessment across end-to-end PV operations.
The position plays a critical role in maintaining the SPVG Regulatory Intelligence system, supporting compliance, training initiatives, and customer-specific regulatory deliverables.
Key Responsibilities
Maintain expert-level knowledge of current and emerging global pharmacovigilance regulations and safety requirements
Conduct ongoing surveillance of regulatory authority websites, global and regional health agencies, and industry publications
Assess the impact of new or revised pharmacovigilance regulations on operational processes and compliance
Update, manage, and maintain the SPVG Regulatory Intelligence system and document repositories
Perform peer reviews to ensure accuracy, completeness, and consistency of regulatory intelligence data
Lead regulatory intelligence impact assessments for assigned items, coordinating input from cross-functional subject matter experts
Conduct country-specific regulatory searches and liaise with regulatory authorities as required
Prepare and distribute regulatory update summaries for internal stakeholders and external customers
Contribute to the development and review of training materials, regulatory intelligence proposals, and quality and compliance documentation
Respond to inquiries through the SPVG Regulatory Intelligence mailbox and support customer-specific RI deliverables
Participate in internal meetings and regulatory forums as required
Required Qualifications & Experience
Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Law, or a related discipline; equivalent experience considered
Minimum 5–8 years of professional experience in Safety and Pharmacovigilance, preferably within a CRO or pharmaceutical environment
Strong understanding of clinical trial processes across Phase II–IV and post-marketing safety activities
In-depth knowledge of ICH GCP, GVP modules, and global pharmacovigilance regulations
Proven experience in regulatory intelligence, safety compliance, or PV operations
Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook
Excellent written and verbal communication, presentation, and stakeholder engagement skills
Strong organizational, documentation, and time-management capabilities with high attention to detail
Ability to work independently, manage multiple priorities, and meet tight deadlines
Why Join Syneos Health
Opportunity to work on global pharmacovigilance and regulatory intelligence initiatives
Exposure to innovative clinical and post-marketing safety programs across multiple regions
Structured career development, technical training, and leadership support
Inclusive, diverse workplace culture centered on the Total Self philosophy
Competitive compensation and comprehensive total rewards program
Compliance & Equal Opportunity Statement
This job description outlines the primary responsibilities of the role but is not intended to be exhaustive. Syneos Health reserves the right to modify duties and responsibilities based on business needs. Equivalent combinations of education, experience, and skills may be considered.
Syneos Health is an equal opportunity employer and complies with all applicable employment legislation, including the EU Equality Directive and the Americans with Disabilities Act (ADA). Reasonable accommodations will be provided to qualified individuals with disabilities.
About Syneos Health – Key Facts
Partnered with 94% of novel FDA-approved drugs in the past five years
Supported 95% of EMA-authorized products
Conducted 200+ studies across 73,000 sites involving more than 675,000 clinical trial participants worldwide
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
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Frank Scottile Blvd |Missouri :
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Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
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Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
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Dún Laoghaire |Galway :
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Netherlands |Remote Australia :
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Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Uxbridge | Renfrew | Richmond Hill | Australia | North York | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
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Ho Chi Minh City |Italy :
Italy |Lombardy :
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Jakarta |East Java :
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Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
Lima |France :
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Midrand | South Africa |Nišava District :
Niš |Bohemia :
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