Position: PV Data Assurance Professional
Job ID: 1759
Location: Bengaluru, India
Astellas is a global pharmaceutical company committed to excellence in pharmacovigilance (PV) and case management. The company focuses on ensuring operational efficiency, data quality, and compliance with global standards across ICSRs and literature case management.
Responsible for the development and maintenance of excellence in Data Assurance within PV Case Management. Focus on operational aspects of ICSRs and literature, ensuring quality, consistency, and efficiency across regions and case processing vendors.
1. ICSR and Safety Information Processing
Implement global ICSR case processing policies and strategies.
Create and maintain conventions, tools, and processes for non-medical review and assessment of ICSRs and literature, including:
Case intake
Data entry (including case narratives)
Unblinding
Quality control and monitoring performed by vendors.
Manage incoming safety information from co-licensors, partners, affiliates, and third parties.
2. Quality, Data Assurance, Training & Business Information Management
Represent PV Case Management in inspections, audits (PV, GMP, GCP) as a subject matter expert.
Justify Astellas’ case assessment decisions to external authorities.
Review and monitor key compliance and quality metrics to drive continuous quality improvement.
3. Capacity Management, Oversight & Budget
Support global case flow capacity management through accurate forecasting for developmental and post-marketing activities.
Ensure business continuity and resource planning adaptation.
Assist in evaluation, selection, onboarding/training of outsourced resources and issue escalation.
4. Regional Knowledge & Accountability
Maintain awareness of regulatory requirements in key regions (USA, EU/EEA).
Keep up-to-date with all regulatory guidelines for intake, review, and reporting of safety information.
5. People & Organization Management
Implement organizational structures that optimize resource use globally.
Manage recruitment, performance, development planning, and retention of high-performing PV Case Management teams.
6. Strategy Development and Execution
Lead PV Data Assurance regional team to support global policies and standards.
Implement PV Case Management operational support tools to ensure quality and consistency.
7. Training
Train and educate Vendor and PV Case Management staff.
Represent PV in cross-functional training sessions promoting PV awareness.
Provide specialist education to PV and non-PV staff.
Conduct PV Case Management overviews for new employees in Data Assurance.
Education: Minimum BA/BS; advanced professional degree preferred.
Experience:
Minimum 5 years in PV or combined PV/RA/QA/clinical development.
Leadership experience managing global, multidisciplinary teams.
Knowledge:
Safety regulations for marketed and investigational products.
Global health authority requirements (ICH, CFR 21, FDAAA, EU GVP, JP regulations).
ICSR processing regulatory requirements for assigned region.
Process management, standards, and training across the product lifecycle.
Skills:
Establishing and maintaining GxP Quality Management Systems.
Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
Goa | Panaji | Verna |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
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Baddi | Solan |India :
Siliguri |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Odisha :
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Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
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Rangpo |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |West Bengal :
Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Albama :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |Arkansas :
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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 :
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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 :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |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 | 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 :
Concord | Lumberton | North Carolina |North Caroline :
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 :
Ambler | Bethlehem | Collegeville | Harrisburg | Lancaster | Marietta | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Pottstown | Radnor | Sellersville | Southampton | Spring House | West Chester | Wyomissing |Portugal :
Lisbon | Oeiras | Portugal |Puerto Rico :
San Juan |Republic of Mexico :
Mexico |South Carolina :
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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 |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 :
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Big Piney | Cokeville |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
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Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Rotherbaum :
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Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |Belgium :
Wavre |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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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 :
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Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
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Amsterdam |Netherlands :
Netherlands |Noord Holland :
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 :
Mississauga | Richmond Hill | Renfrew | North York | Uxbridge | Australia |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 :
Lyon | Paris |Attica :
Koropi | Athens |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Be'Er Sheva | Yavne | Kfar Saba | Tel Aviv | Netanya |Italy :
Italy |Lombardy :
Rho |Japan :
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Almaty |Remote Korea :
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Seoul |Kuala Lumpur :
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New Zealand |North Island :
Auckland |Lima Region :
Lima |Cebu Province :
Cebu City |Philippines :
Manila |Mazovia :
Warsaw |Remote :
Lousiana | Manipal | Remote - Middle East | Switzerland | Faridabad | Belgium | French | Melbourne | Hungary | McFarland | Medan | Zaragoza | Minnesota | Bishop | Bountiful | Riga | Remote - South America (Latin Americal) | Slovakia | Springville | Remote, USA | Remote - Europe | Lenexa | Xzagreb | Remote - Africa | Leinster | Tulsa | Hammond | Ireland | Thailand | Texas | Castlebar | Nairobi | Blue Bell | Green Way | Remote | Victoria |Bucharest :
Bucharest |Makkah :
Khulais | Rabigh | Riyadh | King Abdullah Economic City | Jeddah | 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 :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |