Instagram
youtube
Facebook

Safety & Pv Ops Specialist I

2+ years
Not Disclosed
10 Aug. 29, 2025
Job Description
Job Type: Hybrid Education: Bachelor’s degree in life sciences, nursing, pharmacy, computer science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

🧾 Job Title: Safety & PV Ops Specialist I

Job ID: 25000428
Location: IND – Gurugram (Hybrid)
Updated: August 22, 2025


🧬 About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions company that combines clinical development, medical affairs, and commercial capabilities to bring therapies to market faster. With 29,000 employees in over 110 countries, we’re driven by the mission to change lives through innovation and collaboration.

“WORK HERE MATTERS EVERYWHERE”


💼 Why Join Us?

  • 🌍 Global exposure in a leading CRO environment

  • 🚀 Career growth through technical training, mentorship, and leadership support

  • 🌱 Commitment to diversity, inclusion, and authenticity through our Total Self Culture

  • 🏆 Recognition through performance-based rewards

  • 🤝 Work on cutting-edge projects supporting novel FDA and EMA drug approvals


🎯 Role Summary

The Safety & PV Ops Specialist I provides operational support to the Safety and Pharmacovigilance (PVG) Business Unit. You will assist delivery leads in managing systems setup, documentation, training, compliance, and other department-level tasks to support operational excellence.


🔍 Key Responsibilities

📁 General Support

  • Maintain repositories for training records, finance trackers, proposals, RFI libraries, metrics, and audits/inspections

  • Develop and update process documents and job aids

  • Stay informed on FDA/EU/ICH safety and PV regulations

  • Track SPVG metrics and financial data for accurate business recognition

  • Perform ad-hoc duties as assigned (limited travel up to 15%)


🧪 Quality & Compliance

  • Support development, revision, and control of departmental documents and SOPs

  • Help perform quality checks and track quality metrics

  • Identify risk areas and communicate them for resolution

  • Support audit and inspection readiness across safety project teams


📚 Training

  • Develop and deliver training materials (planned or ad hoc)

  • Oversee Learning Management System (LMS) for Safety & PVG

  • Create PV-specific training modules for accreditation programs


🖥️ Technology & Systems

  • Participate in system audits and demos

  • Support implementation and validation of Safety Systems

  • Configure and maintain Argus Safety database per sponsor requirements

  • Troubleshoot and train users on Argus, ArisG, Clintrace, and other safety systems

  • Generate and QC listings, reports, and queries from safety databases

  • Develop Argus-related training materials and mentor junior Safety Application Specialists

  • Plan and execute safety system data migrations and custom reports

  • Maintain expertise in safety and PVG systems through workshops and internal meetings


📊 Proposals & Business Support

  • Contribute to proposal strategy and development for Safety & PVG components

  • Ensure accuracy in budgets, scope of work, and proposal responses (RFPs/RFIs)

  • Attend bid defense and project hand-over meetings as needed

  • Maintain and update SPVG proposal templates, costing models, and presentation slides

  • Analyze financial data to align with gross profit (GP%) targets


✅ Required Qualifications

Education

  • Bachelor’s degree in life sciences, nursing, pharmacy, computer science, or related field

  • Equivalent education and experience may be considered

Experience & Technical Skills

  • Familiarity with safety database systems and medical terminology

  • Experience in clinical research, data collection, or safety operations preferred

  • Knowledge of ICH guidelines, GCP, and pharmacovigilance regulations

  • Strong computer skills, especially in:

    • Microsoft Office Suite (Word, Excel, PowerPoint, Visio)

    • Oracle Insight/Analytics, Data Mart, Crystal Reports/Business Objects, SQL Plus (preferred)

Competencies

  • Excellent communication and interpersonal skills

  • Strong organizational and documentation abilities

  • Detail-oriented with high accuracy and decision-making skills

  • Ability to multitask, prioritize, and manage competing deadlines

  • Comfortable working independently and in a team

  • Willingness to travel (up to 15%)


🌍 About Syneos Health (Quick Facts)

  • Worked with 94% of all novel FDA-approved drugs in the last 5 years

  • Partnered in 95% of EMA-authorized products

  • Supported 200+ studies across 73,000 sites and 675,000+ trial patients

Explore more at: www.syneoshealth.com


🔎 Additional Notes

  • Job responsibilities are not exhaustive and may change based on company needs

  • Equivalent qualifications will be considered

  • The role complies with global labor laws, including the EU Equality Directive and ADA (reasonable accommodations available)


📝 Summary

This position supports operational activities in the Safety & Pharmacovigilance BU, including training, documentation, system setup, compliance, proposal development, and process improvement. You will assist safety delivery leads and work closely with internal stakeholders to drive compliance and operational efficiency.


📬 How to Apply


🌈 Diversity & Inclusion Commitment

We’re committed to a workplace that fosters diversity, inclusion, and authenticity. If your experience doesn’t exactly match the job description, we still encourage you to apply. We value transferable skills and unique perspectives.

Latest Jobs

Senior Medical Writer (Redaction)

Syneos Health
Gurugram

Safety & Pv Ops Specialist Ii - Technology Support (Argus Console Or Veeva Safety Preferred)

Syneos Health
Remote

Senior Medical Writer

Syneos Health
Remote

Senior Medical Writer

Syneos Health
Gurugram

Medical Writer Ii (Csr Narratives)

Syneos Health
Remote

Medical Writer Ii (Csr Narratives)

Syneos Health
Gurugram

Senior Medical Writer (Ctt & Redaction)

Syneos Health
Remote

Senior Medical Writer (Ctt & Redaction)

Syneos Health
Gurugram

Medical Writer Ii (Csr Narratives)

Syneos Health
Aachen Abbott Park Aberdeen Abilene Adelanto Ahmedabad Airoli Alameda Albany Albion Albuquerque Almaty Ambala Ambernath Ambler Amravati Amsterdam Anakapali Anantapur Anchorage Andover Ankleshwar Annamalainagar Appleton Arcata Argentina Arizona Arkansas Arlington Athens Atherton Atlanta Auckland Augusta Aurangabad Austin Australia Austria B.G Nagara Baddi Ballina Ballydine Baltimore Banasthali Bangalore Bangkok Bangor Barcelona Baroda Barrow Basel Basking Ridge Batavia Bathinda Baton Rouge Bavaria Bayreuth Be'Er Sheva Beijing Bel Air Bela Belgaum Belgium Belgrade Bellevue Bend Bengaluru Berkeley Berlin Bethel Bethlehem Bharuch Bhimavaram Bhiwadi Bhopal Bhubaneswar Biberach an der Riß Biddle Bielefeld Big Piney Bilaspur Billerica Birmingham Bishop Blacksburg Bloomfield Bloomingdale Bloomington Blue Ash Blue Bell Boca Raton Bochum Boerne Bogota Boise Bommasandra Bonn Boston Bothell Boulder Bountiful Branchburg Township Brazil Breda Brenham Brentwood Brewer Bridgeport Bridgewater Brinny Brisbane Bristol Brooklyn Brooksville Brunswick Brussels Bucharest Budapest Buenos Aires Buffalo Buffalo Grove Bulgaria Bulverde Burlingame Burlington Burney Cairo California Cambridge Canada Carlow Carlsbad Carolina Beach Carrollton Castlebar Cebu City Cedar Hill Champaign Chandigarh Chandler Chapel Hills Charleston Charlotte Charlottesville Chengdu Chennai Chessington Cheverly Chicago China Chittoor Cincinnati Ciudad de México Clark Clayton Clearwater Cleveland Coimbatore Cokeville Collegeville Cologne Colorado Columbia Columbus, Concord Cooper City Copenhagen Coquille Coral Gables Coral Springs Cork Corpus Christi Corsicana Corvallis Cranbury Crescent City Croatia Czech Republic Dalian Dallas Darmstadt Davis Dayton Daytona Beach Deerfield Dehradun Delhi Denmark Denton Denver Detroit Devens Dewas Dhule Dibrugarh Diburghar Dickinson Digha Dombivali Donegal Dortmund Downers Grove Downey Dubai Dublin Duisburg Duluth Dún Laoghaire Dunboyne Dunellen Durham Dusseldorf East Brunswick Eden Prairie Edgewood Edison El Monte El Paso El Segundo Elkridge Emeryville Enfield England Eot Municipality Erie Erlangen Erode Estonia Eugene Eureka Evendale Fairfield fairmont Falls Church Far Hills Faridabad Farmington Finland Flemington Florence Florida Fort Smith Fort Worth Fortuna Foster City France Frank Scottile Blvd Frankfurt Franklin Freiburg Fremont French Friday Harbor Fridley Ft MItchell Fulton Gainesville Gaithersburg Gajraula Galway Gandhinagar Garden city Garland Gautam buddha Nagar Georgia Germany GErmany Ghaziabad Glendale Glenview Goa Goldendale Gorakhpur Gottingen Grants Pass Greater Noida Greece Green Way Grenzach Groton Gujarat Guntur Gurgaon Gurugram Guwahati Gwalior Hà Nội Haarlem Hackensack Hajipur Halifax Halle Halol Hamburg Hamilton Hammond Hangzhou Hannover Hanoi Hanumakonda Harlow Harrisburg Harrogate Hartford Harveysburg Haryana Hauppauge Hawai Hawthorne Hayward Hebron Heidelberg Heist op den Berg Hibbing Hicksville Hilo Hisar Ho Chi Minh City Holly Springs Hollywood Honolulu Hoopa Hopewell Houghton Lake Houston Huber Heights Hungary Hyderabad India Indianapolis Indore Ingelheim am Rhein Ireland Irvine Istanbul Italy Ithaca Jacksonville Jaipur Jakarta Jalgaon Japan Jeddah Jersey City Jhagadia Jhansi John Day Juneau Kannur Kansas City Karlsruhe Karnataka Keene Kenosha kentucky Kfar Saba Khandwa Khargone Khulais Kiel King Abdullah Economic City Kingman Kings Mills Knoxville Kochi Kolhapur Kolkata Konstanz Koropi Kuala Lumpur Kurkumbh Kurla Kurukshetra Kyiv La Jolla Lake Charles Lake Forest Lake Havasu City Lake Oswego Lakeview Lakeway Lancaster Largo Larne Las Vegas Latvia Lawrence Lebanon Leeds Leiden Leinster Leipzig Lendava Lenexa Leuven Lexington Lima Limerick Linden Linthicum Lisbon Livingston Lombard London Longview Los Angeles Louisville Lousiana Lucknow ludhiana Lumberton Lyndhurst Lyon Macedonia Macomb Macon Madhapur Madison Madrid Madurai Mahabubnagar Mahwah Maidenhead Mainz Maitland Malappuram Malaysia Manchester Mangalagiri Mangaluru Manila Manipal Maple Grove Marburg Marietta Marsa Martinez Mason Massachusetts Mathura Mcallen McFarland McKinleyville McPherson Mechanicsville Medak Medan Medford and Somerville Mehsana Melbourne Memphis Menlo Park Mesa Mexico Miami Michigan Middleburgh Middletown Midrand Milan Milford Millbrae Milpitas Minneapolis and St. Paul, Minnesota. Minnesota Minnetonka Mississauga Mitte Moga Mohali Monmouth Junction Monroe Montgomery Montreal Montville Morgan Hill Morningside Heights Morrisville Mount Arlington Mount Vernon Mountain View Mt. Pleasant Mukundapur Mumbai Munich Munster Mysore Nagercoil Nagpur Nainital Nairobi Najran Naperville Naples Narsapur Nashik Nashville Navi Mumbai Nebraska City Nedlands Nellore Netanya Netherlands Nevada New Brunswick New Delhi New Hampshire New Haven New Jersy New Orleans New York New Zealand Newark Newtown Niš Noida Norridge North Carolina North Miami Beach North Richland Hills North York Norway NOrway Norwood Novato Nutley Oakland Oeiras OH Oklahoma City Ooty Orange Oregoina Orlando Osaka Otemachi Oulu oxford Pacheco Palo Alto PAN-India Panaji Panchkula Paramus Paris Park City Park RIdge Parsippany Pasadena Passaic Paterson Patiala Patna Peapack-Gladstone Pearl River Pembroke Pines Peridot Peru Phagwara Philadelphia Philippines Phoenix Piedmont Pilani Pine Brook Pirbright Piscataway Township Pithampur Pittsburgh Plainsboro Plano Plantation Pleasant Prairie Pleasanton Plymouth Meeting Poland Pomona Pondicherry (Puducherry) Port St. Lucie Portage Portland Portugal Pottstown Poughkeepsie Prague Prayagraj Princeton Junction Pudupakkam Pullman Pune Pune city Pydibimavaram Quarry Bay Queensland Rabigh Radnor Rahway Raipur Rajpura Raleigh Ranchi Rangareddy Rangpo Raritan Redding Redwood City Reedsport Regensburg Remote Remote - Africa Remote - Europe Remote - Middle East Remote - South America (Latin Americal) Remote Australia Remote Korea Remote, USA Renfrew Rensselaer Rhinebeck Rho Richardson Richmond Hill Riga Ringaskiddy Rishikesh Riverside Riyadh Rockland Rockville Rocky Mount Rohtak Romania Rome Roorkee Roseburg Roseville Rostock Round Lake Rourkela Rueil-Malmaison Runcorn Saarbrucken Sacramento Saint Petersburg Saitama Salem Salisbury Salt Lake City San Antonio San Bernardino San Carlos San Diego San Francisco San Gabriel San Jose San Juan San Mateo San Rafael Sanford Santa Clara Santa Cruz Santa Fe Santa Monica Santiago Sao paulo Sarajevo Sarasota Satyamev Scottsdale Seattle Seguin Sellersville Seoul Serbia Shanghai Shi Sheffield Shelbyville Sherwood Shirpur Shivalik Shreveport Siliguri Simi Valley Singapore Sitka Slovakia Slovenia Sofia Solan Soledad Somerset Somerville South Africa South Plainfield South San Francisco South Windsor South Yarra Southampton Southfield Spain Sparta Spring House Springfield Springville Srivilliputtur St. Helena St. Louis St.Paul Stamford Stanford Stanton Stevenage Stirling Stockton Storrs Stuart Stuttgart Summit Sunnyvale Surabaya Surprise Sweden Switzerland Swords Sydney Sylmar Syracuse Tacoma Taipei Tallahassee Tallinn Tampa Tandalja Tarapur Tarasadi Tartu Tel Aviv Temecula Tempe Texas Thailand Thane Thiruvananthapuram Thousand Oaks Tiruchirappalli Tirupathi Titusville Tokyo Tonopah Tonopsh Towson Trenton Trichy Trivandrum Tubingen Tucson Tucumcari Tulsa Turkey Turku Tuscaloosa Tyler Udaipur Udupi Ujjain Ulm United Kingdom United States Upper Marlboro Utica Uxbridge Vadodara Valencia Vallejo Vancouver Vapi Varanasi Vedant Vellore Venica Verna Victoria Vienna Vietnam Vijayawada Vikhroli Virginia Visakhapatnam Waco Warren Grove Warsaw Washington Waterford Watertown Waukesha Wausau Wavre Waynesville Welwyn West Chester West Hartford West Lafayette West Orange West Palm Beach West Sacramento West Valley City Westfield Westminster Wharton Whippany White Plains Whitesboro Whittier Willits Wilmington Winston-Salem Winter Haven Witney Woodburn Woonsocket Wrangell Wuhan Wurzburg Wyomissing Xzagreb Yavne Yerawada Yogyakarta Yuma Zagreb Zaragoza Zaventem Zurich

Senior Medical Writer (Ctt & Redaction)

Syneos Health
Remote