Job ID: 25000428
Location: IND – Salem (Hybrid)
Updated: August 22, 2025
Syneos Health® is a fully integrated biopharmaceutical solutions company supporting clinical development, medical affairs, and commercial operations. With 29,000 employees in 110 countries, we help accelerate biopharma success and improve patient outcomes through insights, innovation, and operational excellence.
“WORK HERE MATTERS EVERYWHERE”
🚀 Career growth through development programs, training, and internal mobility
💡 Work with a global leader driving 94% of novel FDA approvals and 95% of EMA-authorized products
🌱 Inclusive, diverse culture via our Total Self initiative
🏆 Recognition and rewards program
🤝 Flexible hybrid work environment
The Safety & PV Ops Specialist I will assist in providing operational support across multiple areas within the Safety & Pharmacovigilance (SPVG) Business Unit. Responsibilities include document management, system configuration, training, quality compliance, metrics tracking, and support of safety databases and proposals.
Maintain repositories for documents (training records, RFI libraries, audits, metrics, etc.)
Develop and update job aids, SOPs, and process documentation
Stay current on FDA/EU/ICH safety and PV regulations
Support revenue recognition by aligning with BU PMs and Directors
Provide SPVG metrics at regular intervals
Perform additional assigned duties
Travel up to 15% (minimal)
Assist in developing and managing controlled documents
Track and report quality compliance metrics
Identify and communicate risk areas via risk-based assessments
Coordinate with internal QA teams to resolve open quality issues
Support audit readiness for safety project teams
Design, update, and deliver training materials for Safety and PVG teams
Collaborate with leadership to ensure relevant training content
Manage Learning Management System (LMS)
Develop PV-specific modules for accreditation programs
Participate in audits and system demonstrations
Assist in implementation, validation, and documentation of Safety Systems
Maintain departmental SOPs/WIs for Safety Systems
Configure and maintain Argus Safety database based on sponsor needs
Troubleshoot safety systems (Argus, ArisG, Clintrace, sponsor-specific systems)
Create Argus forms (project info, licenses, user access, report requests)
Develop, test, and maintain reporting tools (e.g., Business Objects)
Support data migrations and custom safety system reports
Train and mentor junior team members
Represent the Safety Applications team at internal/external meetings
Stay up-to-date with regulatory compliance, ICH, GCP, and global guidelines
Support annual GP% targets by tracking costing model inputs
Participate in strategy discussions and bid defense meetings
Prepare budget text and scope of work for RFPs/RFIs
Collaborate with Contracts and BU PMs to manage budget and scope changes
Maintain SPVG proposal templates, costing models, and slide decks
Bachelor's degree in life sciences, nursing, pharmacy, computer science, or related field
Equivalent experience may be considered
Familiarity with safety databases and medical terminology
Clinical research/data management experience preferred
Working knowledge of relational databases and safety reporting tools
Oracle Insight/Analytics/Data Mart, Crystal Reports/Business Objects, SQL Plus preferred
Strong understanding of ICH/GCP/regulatory guidelines
Advanced skills in Microsoft Office (Word, Excel, PowerPoint, Visio)
Ability to manage multiple tasks, work independently and within a team
Excellent communication, documentation, and presentation skills
Attention to detail with strong problem-solving ability
Decision-making and time management capabilities
Travel: up to 15% (as needed)
Partnered in:
94% of all novel FDA approvals (past 5 years)
95% of EMA-authorized drugs
Conducted 200+ studies at over 73,000 sites with 675,000+ trial participants
Explore more: www.syneoshealth.com
Responsibilities may change based on business needs
Equivalent experience or education may be considered
Compliant with EU Equality Directive and Americans with Disabilities Act (ADA)
Reasonable accommodations provided when appropriate
This role provides operational and systems support to the Safety & Pharmacovigilance Business Unit, including project support, systems setup, training delivery, audit readiness, proposal development, and compliance tracking. You will collaborate with cross-functional teams and contribute to global clinical safety initiatives.
👥 Not ready? Join the Talent Network
At Syneos Health, we believe diverse perspectives strengthen innovation. Even if your background doesn’t perfectly match, we encourage you to apply. Transferable skills are welcomed.
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Dibrugarh | Diburghar | Guwahati |Bihar :
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Bilaspur | Eot Municipality | Raipur |Delhi :
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Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
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Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Colorado | Czech Republic | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Madhya Pradesh :
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Pondicherry (Puducherry) :
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Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Sikkim :
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Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Uttar Pradesh :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |West Bengal :
Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Albama :
Tuscaloosa |Arizona :
Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |Arkansas :
Fort Smith |California :
Adelanto | Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burlingame | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hayward | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Millbrae | Milpitas | Morgan Hill | Mountain View | Nevada | Novato | Oakland | Orange | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Carlos | San Diego | San Francisco | San Gabriel | San Jose | San Mateo | San Rafael | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | St. Helena | Stanford | Stanton | Stockton | Sunnyvale | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |D.C :
Washington |Delaware :
Wilmington |Florida :
Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Gainesville | Hollywood | Jacksonville | Maitland | Marsa | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Sarasota | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Georgia :
Atlanta | Augusta | Rome |Hawaii :
Hilo | Honolulu |Idaho :
Boise |Illinois :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |Kentucky :
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Frank Scottile Blvd |LA :
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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 :
Fulton | Milan | St. Louis |Nebraska :
Hebron | Nebraska City |Nevada :
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Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |New Mexico :
Albuquerque | Farmington | Santa Fe | Tucumcari |New York :
Albany | Biddle | Brooklyn | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |North Carolina :
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Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |North Dakota :
Dickinson |northeastern :
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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 :
Oklahoma City |Oregon :
Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Pennsylvania :
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Mexico |South Carolina :
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Knoxville | Memphis | Nashville |Texas :
Abilene | Arlington | Austin | Boerne | Brenham | Bulverde | Carrollton | Cedar Hill | Corpus Christi | Corsicana | Dallas | Denton | El Paso | Fort Worth | Garland | Houston | Lakeway | Longview | Mcallen | North Richland Hills | Plano | Richardson | San Antonio | Seguin | Tyler | Waco |United states :
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 :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Washington :
Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |WI :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |Wyoming :
Big Piney | Cokeville |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |Germany :
Germany | GErmany |Hesse :
Darmstadt | Marburg |Hessen :
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 :
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Brinny | Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
Dún 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 :
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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 :
Australia | Mississauga | North York | Richmond Hill | Uxbridge | Renfrew |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
Bogota |Croatia :
Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Lyon | Paris |Attica :
Athens | Koropi |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Be'Er Sheva | Netanya | Kfar Saba | Yavne | Tel Aviv |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 México |North Island :
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Manila |Mazovia :
Warsaw |Remote :
Xzagreb | Nairobi | Lousiana | Remote - Middle East | Green Way | Tulsa | Remote - Africa | Riga | Castlebar | Medan | Zaragoza | Victoria | Belgium | Remote - South America (Latin Americal) | Remote | Lenexa | Faridabad | Ireland | Minnesota | Bishop | Leinster | Manipal | Melbourne | Springville | Bountiful | Remote - Europe | Blue Bell | McFarland | Switzerland | Hungary | Slovakia | Remote, USA | Texas | Thailand | French | Hammond |Bucharest :
Bucharest |Makkah :
Riyadh | Khulais | Jeddah | Rabigh | King Abdullah Economic City | Najran |Nišava District :
Niš |Singapore :
Singapore |South Africa :
South Africa | Midrand |Brazil :
Sao paulo | Brazil |South America :
Argentina | Peru |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
Bangkok |Kyiv Oblast :
Kyiv |Dubai :
Dubai |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |