Safety & PV Ops Specialist I
Hyderabad, India – Hybrid
25000428
Posted Date: August 22, 2025
Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success. We bring clinical, medical affairs, and commercial capabilities together with a focus on real-world results.
Our global team of 29,000 employees across 110 countries is passionate about transforming life sciences by placing the customer and the patient at the center of everything we do.
๐ Learn more: syneoshealth.com
Career development & clear growth opportunities
Supportive leadership and team culture
Recognition programs and total rewards
Technical & therapeutic training
Total Self Culture: Be your authentic self in an inclusive, diverse environment
WORK HERE MATTERS EVERYWHERE.
You will provide operational support across multiple areas of the Safety & Pharmacovigilance (PV) Business Unit (BU). This includes assisting delivery leads with training, documentation, systems setup, and access requests. You'll also be involved in department-wide process improvement initiatives and tools development.
Maintain repositories for training, finance, RFI library, and project metrics
Create and update process documents and job aids
Stay current on FDA/EU/ICH PV reporting regulations
Support revenue recognition in collaboration with PMs and SPVG teams
Generate SPVG metrics periodically
Perform other duties as assigned
Up to 15% travel may be required
Support quality planning through controlled document management
Perform and track quality control activities and compliance metrics
Identify risks via process assessments and coordinate with Corporate Quality Assurance (CQA)
Ensure audit and inspection readiness across safety project teams
Create, present, and track training materials for the PV BU
Coordinate with leadership to update training content
Provide oversight of Learning Management System (LMS)
Develop PV-specific modules for internal accreditation programs
Participate in audits and provide system demos
Support Safety System validation, documentation, testing, and SOP/WI updates
Administer and maintain Argus Safety database per project
Develop and maintain safety reporting tools (e.g., Business Objects)
Configure Argus components (products, users, reports, etc.)
Troubleshoot Argus, ArisG, Clintrace, and other sponsor databases
Train and mentor junior application specialists
Plan and execute data migrations and reporting projects
Maintain regulatory compliance (GCP, ICH, SOPs, WIs)
Represent Safety Applications in client and project meetings
Contribute to SPVG gross profit targets through budgeting support
Attend activation calls and collaborate on proposal strategy
Draft accurate proposal content, scope, and budgets for RFPs/RFIs
Coordinate with contracts and project managers on scope changes
Maintain proposal templates, costing models, and SPVG slides
Support bid defenses and project handovers as needed
Bachelor’s degree in Life Sciences, Nursing, Pharmacy, Computer Science, or related field
Equivalent experience may be considered
Strong exposure to clinical research, PV operations, or CRO environments preferred
Experience with safety databases (e.g., Argus, ArisG) and medical terminology
Knowledge of ICH guidelines, GCP, FDA/EU PV regulations
Proficient in relational databases (Oracle Insight, Data Mart, SQL, Crystal Reports, Business Objects)
Advanced MS Office skills (Excel, Word, Visio, PowerPoint, Outlook)
Strong communication (written & verbal)
Analytical and documentation skills
Ability to prioritize and multitask across multiple projects
Decision-making and problem-solving mindset
Detail-oriented and deadline-focused
Team player and independent contributor
Duties may evolve based on business needs
The company may determine role equivalency based on experience
This is not an employment contract
Reasonable accommodations available per the Americans with Disabilities Act (ADA)
Syneos Health promotes equal opportunity and inclusion across all regions
In the last 5 years, Syneos Health has:
Worked on 94% of novel FDA-approved drugs
Supported 95% of EMA-authorized products
Participated in 200+ studies across 73,000+ sites involving 675,000+ trial patients
We challenge the status quo every day—and invite you to do the same.
If you’re ready to make a difference in global health, [Apply for this job now].
Not ready yet? [Join our Talent Network] to stay connected for future opportunities.
๐ Encouraged to apply even if your experience doesn’t fully match the job description—we value transferable skills.
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Bangor | Brewer |Maryland :
Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro | White Plains |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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Hebron | Nebraska City |Nevada :
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Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Montgomery | Norwood | Oregoina | oxford | Waynesville |Oklahoma :
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Mexico |South Carolina :
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Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |United States :
Hawai | kentucky | Sylmar | Woonsocket |Virginia :
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Biberach an der Riร | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |Germany :
Germany | GErmany |Hesse :
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Frankfurt | Harveysburg |Lower Saxony :
Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Rotherbaum :
Hamburg |Saarland :
Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |Belgium :
Wavre |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Hungary :
Budapest |Istanbul :
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Basel | Zurich |Carlow :
Carlow |Cork :
Brinny | Ringaskiddy |County Dublin :
Swords |Dรบn Laoghaire :
Dรบn Laoghaire |Galway :
Galway |Meath :
Dunboyne |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Tipperary :
Ballydine |Ulster :
Donegal |China :
China | Quarry Bay |Hubei :
Wuhan |Liaoning :
Dalian |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
South Yarra |New South Wales :
Ballina | Sydney |Queensland :
Queensland |Remote Australia :
Arkansas | Remote Australia |Republic of Western Australia :
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Amsterdam |Netherlands :
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Haarlem |North Brabant :
Breda |South Holland :
Leiden |North Yorkshire :
Harrogate |Oxfordshire :
Witney |South Yorkshire :
Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Uxbridge | Australia | North York | Richmond Hill | Renfrew | Mississauga |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
Bogota |Croatia :
Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Paris | Lyon |Attica :
Koropi | Athens |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Be'Er Sheva | Tel Aviv | Netanya | Yavne | Kfar Saba |Italy :
Italy |Lombardy :
Rho |Japan :
Japan | Saitama |Tokyo :
Otemachi |Kazakhstan :
Almaty |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kuala Lumpur :
Kuala Lumpur |Mexico :
Ciudad de Mรฉxico |New Zealand :
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Auckland |Lima Region :
Lima |Cebu Province :
Cebu City |Philippines :
Manila |Mazovia :
Warsaw |Remote :
Ireland | Nairobi | Springville | Xzagreb | Leinster | Thailand | Manipal | Switzerland | Minnesota | Castlebar | Remote - Africa | Texas | Belgium | Tulsa | Remote - South America (Latin Americal) | Victoria | Green Way | Bountiful | Remote - Europe | Blue Bell | Medan | Zaragoza | McFarland | Hammond | Slovakia | Riga | Remote - Middle East | Bishop | Remote, USA | Lenexa | Faridabad | Lousiana | French | Remote | Melbourne | Hungary |Bucharest :
Bucharest |Makkah :
Najran | Jeddah | King Abdullah Economic City | Khulais | Rabigh | Riyadh |Niลกava District :
Niลก |Singapore :
Singapore |South Africa :
Midrand | South Africa |Brazil :
Brazil | Sao paulo |South America :
Argentina | Peru |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
Bangkok |Kyiv Oblast :
Kyiv |Dubai :
Dubai |Hร Nแปi :
Hanoi | Hร Nแปi |Ho Chi Minh :
Ho Chi Minh City |