Associate Director, Safety Enablement & Organizational Readiness
Function: Product Safety
Sub Function: Drug & Product Safety Operations
Category: Senior Manager (P8), Drug & Product Safety Operations
Location: Hyderabad / Bangalore / Mumbai, India
Work Pattern: Hybrid
Requisition Number: R-042511
Date Posted: Nov 14, 2025
About Johnson & Johnson
At Johnson & Johnson, health is at the center of everything we do. Through our strengths in Innovative Medicine and MedTech, we are positioned to innovate across the full healthcare spectrum—preventing, treating, and curing complex diseases. Our mission is to deliver smarter, more personal, and less invasive healthcare solutions that advance human health.
Role Overview
The Associate Director, Safety Enablement & Organizational Readiness supports initiatives that strengthen pharmacovigilance (PV) capabilities, ensure regulatory compliance, and enhance operational excellence within Global Medical Safety Operations (GMSO).
The role focuses on process improvement, change management, training, knowledge management, and stakeholder collaboration, ensuring the organization is prepared for evolving regulatory expectations and technological advancements.
Key Responsibilities
1. Operational Excellence & Process Improvement
Support implementation and continuous refinement of standardized PV processes and systems aligned with global regulations.
Identify and resolve operational inefficiencies in safety data management, case processing, and reporting workflows.
Maintain and update SOPs, work instructions, and process maps with cross-functional partners.
Track KPIs and support data-driven decisions to improve compliance and performance.
2. Organizational Readiness & Change Management
Assist in executing change management strategies for new systems, processes, and regulatory updates.
Conduct stakeholder impact assessments and support communication, training, and adoption activities.
Coordinate feedback loops (surveys, focus groups) to evaluate change effectiveness and identify improvements.
3. Training & Knowledge Management
Develop and deliver role-specific PV training to ensure staff are aligned with regulatory expectations and internal processes.
Support creation and maintenance of knowledge repositories, learning modules, and reference materials.
Promote continuous learning across GMSO through structured training programs.
4. Collaboration & Stakeholder Engagement
Partner with Regulatory Affairs, Clinical Development, IT, and Quality Assurance to support integrated safety initiatives.
Maintain productive working relationships with internal teams and external partners.
Facilitate communication, alignment, and knowledge-sharing across stakeholders.
5. Vendor & Project Support
Support vendor oversight activities including performance tracking, issue management, and documentation review.
Assist in planning, execution, and monitoring of safety system implementations and process improvement projects.
6. Project Management & Process Excellence
Manage one or more projects within scope, cost, quality, and timeline requirements.
Ensure alignment, integration, and transparency across GMSO project activities.
Maintain project dashboards, trackers, SharePoint portals, and documentation systems.
Drive decision-making through structured communication with senior leaders and cross-functional teams.
Monitor project progress and identify opportunities for efficiency while maintaining quality.
Prepare dashboards, storyboards, and scorecards to improve visibility of departmental progress.
Provide project status updates and lead stakeholder communications.
Maintain inspection-ready documentation including requirements, objectives, technical files, and lessons learned.
Qualifications
Education
Bachelor’s degree required
Master’s, PhD, or MBA strongly preferred
Experience
Minimum 7+ years in pharmacovigilance or related field
Minimum 2+ years in a leadership or project management role
Knowledge & Skills
Strong understanding of global pharmacovigilance regulations and end-to-end PV operations
Experience in process improvement and change management methodologies
Excellent communication, interpersonal, and collaboration abilities
Proficiency in MS Office tools and familiarity with PV systems and analytics platforms
Required Skills
Good Clinical Practice (GCP)
Serious Adverse Event Reporting
SOP development and management
Risk Management & Compliance
Quality Control (QC)
Safety Investigations
Organizing & Project Coordination
Technical Credibility
Process Improvement & Innovation
Safety-Oriented Mindset
Preferred Skills
Clinical Operations
Compliance Management
Research Ethics
Medicines/Device Development & Regulation
OSHA Compliance
Risk Compliance
Safety Operations Strategy
Gujarat :
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Delhi | India | New Delhi | PAN-India |Assam :
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Siliguri |Illinois :
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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 :
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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 :
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Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |North Caroline :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
Charleston |Kansas :
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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 :
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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
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Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |Portugal :
Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
San Juan |Albama :
Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
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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 :
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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 :
Australia | North York | Mississauga | Richmond Hill | Uxbridge | Renfrew |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Athens | Koropi |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 :
Netanya | Tel Aviv | Yavne | Kfar Saba | Be'Er Sheva |Remote :
Hungary | McFarland | Faridabad | Thailand | French | Castlebar | Nairobi | Lousiana | Manipal | Green Way | Leinster | Hammond | Remote, USA | Melbourne | Switzerland | Minnesota | Remote | Zaragoza | Belgium | Medan | Blue Bell | Remote - Africa | Riga | Texas | Remote - South America (Latin Americal) | Victoria | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Europe | Springville | Tulsa | Lenexa | Bountiful | Bishop | Ireland | Remote - Middle East | Slovakia | Xzagreb |Republic of Colombia :
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Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
Ciudad de México | New Mexico |Dubai :
Dubai |Makkah :
Khulais | Riyadh | King Abdullah Economic City | Jeddah | Najran | Rabigh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
Warsaw |
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