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Position Summary
The Change Management Lead for the GSDM and GPV Help Desk is responsible for monitoring reported incidents and change requests while maintaining and managing GPV safety systems. This role ensures seamless system configurations and validated operations, supporting the organization’s mission to deliver excellence in Pharmacovigilance.
Key Responsibilities
System Maintenance & Configuration
Manage and maintain safety system data and configurations per Otsuka standards, ensuring accuracy and regulatory compliance.
Oversee system validation tasks, collaborating with Testing and Validation teams.
Ensure safety systems remain in a validated state, supporting both daily operations and long-term strategies.
Change Management & Support
Act as a subject matter expert for safety system changes, upgrades, and enhancements.
Oversee incident, change, and problem management using industry best practices.
Manage offshore support teams, ensuring alignment with daily activities and goals.
Monitor and report weekly performance metrics to quantify support efficiency.
Collaboration & Development
Work cross-functionally with GPV teams to gather and address business needs for system upgrades and solutions.
Support GPV Business Intelligence by creating and validating safety data reports, line-listings, and aggregate summaries.
Develop and deliver user training programs on safety systems.
System Implementation & Oversight
Define, design, test, and deploy safety system solutions.
Conduct E2B pilots with regulatory agencies and partners to ensure compliance and innovation.
Support the development of system-related research initiatives and deliver results effectively.
Risk Management & Reporting
Escalate risks and issues to GSDM leadership promptly and effectively.
Provide accurate and timely reporting on incidents, changes, and project statuses.
Knowledge, Skills, and Competencies
Required Knowledge
At least 5 years of experience in Pharmacovigilance/Drug Safety, with expertise in software-based safety systems (Argus experience preferred).
In-depth understanding of clinical trial and post-marketing safety environments in a global setting.
Familiarity with FDA, EU, MHLW, Health Canada, and ICH guidelines.
Knowledge of MedDRA and WHO-DD coding dictionaries.
Skills
Proficiency in PL/SQL, Oracle, SQL Server, Argus Suite, TOAD, and SQL Developer.
Experience with tools like JReport (ver 12/13.1).
Strong presentation, communication, and project management skills.
Advanced computer skills in Microsoft Word, Excel, Access, and PowerPoint.
Education and Experience
Bachelor's degree in Life Sciences or related field.
Minimum 4 years of experience in the pharmaceutical industry.
Experience with pre- and post-marketing in a global environment is highly desired.
Competencies
Accountability for Results: Focus on strategic objectives and drive high standards of performance.
Strategic Thinking & Problem Solving: Make decisions considering long-term business impacts.
Patient & Customer Centricity: Prioritize the needs of patients, customers, and stakeholders.
Impactful Communication: Effectively influence and inspire across all organizational levels.
Respectful Collaboration: Value diverse perspectives and work towards common goals.
Empowered Development: Actively pursue personal and team growth opportunities.
Additional Information
Travel Requirements: Approximately 10%.
Work Environment: Otsuka provides a supportive environment that fosters innovation and collaboration.
Equal Opportunity Employer
Otsuka is committed to diversity and inclusion, welcoming applicants from all backgrounds and providing equal employment opportunities.
Beware of Recruitment Fraud
Otsuka never asks for payment or financial information during the hiring process. If you encounter suspicious recruitment activities, report them to the FBI or your local authorities.
Why Join Otsuka?
Make a Difference: Contribute to improving patient lives with innovative solutions.
Global Collaboration: Be part of a team that values diversity and empowers local decision-making.
Career Growth: Access extensive opportunities for professional development and global mobility.
For more information, visit Otsuka Careers.
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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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 |California :
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Albuquerque | Farmington | Santa Fe | Tucumcari |Pennsylvania :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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 | Newark | New Brunswick | 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 | Westfield | West Orange | Wharton | Whippany |Ohio :
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Baton Rouge | Monroe | New Orleans |Washington :
Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Wyoming :
Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Indiana :
Bloomington | West Lafayette |Florida :
Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Florida | 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 |Idaho :
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Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |North Caroline :
Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |Arizona :
Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
Charleston |Kansas :
Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
Knoxville | Memphis | Nashville |Louisiana :
Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
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Lisbon | Oeiras | Portugal |WI :
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Oklahoma City |Puerto Rico :
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Tuscaloosa |D.C :
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Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
Breda |Noord Holland :
Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Richmond Hill | Mississauga | Uxbridge | Australia | North York | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Sao paulo | Brazil |Attica :
Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Saitama | Japan |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Tel Aviv | Kfar Saba | Netanya | Be'Er Sheva | Yavne |Remote :
Xzagreb | Melbourne | Victoria | Medan | Remote - Europe | Hungary | Castlebar | Bountiful | Manipal | Leinster | Texas | Slovakia | Remote - Africa | Remote - South America (Latin Americal) | Ireland | Remote, USA | Remote - Middle East | Lenexa | McFarland | Tulsa | Remote | Belgium | Minnesota | Thailand | Nairobi | Springville | Regulatory Labeling Manager (NA and LATAM Only) | Lousiana | Hammond | Riga | Blue Bell | Green Way | Bishop | Switzerland | Zaragoza | French | Faridabad |Republic of Colombia :
Bogota |Williamson :
Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
Ciudad de México | New Mexico |Dubai :
Dubai |Makkah :
Jeddah | King Abdullah Economic City | Riyadh | Khulais | Najran | Rabigh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
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