PV Compliance Principal Specialist – QPPV Office
Company: Novo Nordisk Global Business Services (GBS)
Department: QPPV Office & PV Excellence, Global Patient Safety (GPS)
Location: Bangalore, Karnataka, India
Employment Type: Full-Time
About the Role
Novo Nordisk is seeking an experienced PV Compliance Principal Specialist to join the QPPV Office & PV Excellence Team within Global Patient Safety.
This is a strategic pharmacovigilance compliance role responsible for driving global PV quality systems, audit and inspection readiness, QPPV oversight activities, compliance governance, and continuous process improvement across Novo Nordisk's worldwide pharmacovigilance network.
The role requires extensive expertise in pharmacovigilance regulations, inspections, audits, CAPA management, quality systems, and stakeholder engagement. The successful candidate will partner closely with the QPPV, Deputy QPPV, Global Patient Safety leadership, and global affiliates to ensure compliance excellence and patient safety.
Key Responsibilities
PV Audit & Inspection Leadership
Act as the designated Inspection Responsible for Headquarters Pharmacovigilance audits and regulatory inspections.
Coordinate end-to-end inspection readiness activities.
Support on-site, remote, and hybrid inspections.
Manage inspection logistics, documentation, stakeholder preparation, and regulatory submissions.
Lead inspection response coordination with Competent Authorities.
Audit Findings, Deviations & CAPA Management
Coordinate audit and inspection follow-up activities.
Draft and review inspection responses.
Monitor CAPA implementation through closure.
Perform trending and root cause analysis of:
Audit Findings
Inspection Findings
Deviations
Compliance Risks
Drive continuous quality improvement initiatives.
QPPV Office Oversight
Support QPPV Office governance and oversight responsibilities.
Coordinate pharmacovigilance compliance activities across global affiliates.
Ensure effective execution of QPPV oversight processes.
Support strategic compliance initiatives and risk management programs.
PSMF Management
Coordinate preparation, review, and maintenance of:
Global Pharmacovigilance System Master Files (PSMFs)
Local Pharmacovigilance System Master Files (PSMFs)
Ensure PSMF compliance with global regulatory requirements.
Collaborate with affiliates and functional teams to maintain accurate documentation.
QPPV Oversight Meetings
Facilitate and coordinate QPPV Oversight Meetings.
Ensure relevant stakeholders and Subject Matter Experts participate.
Compile compliance metrics and safety data.
Present findings and recommendations to leadership teams.
PV Quality Management System (PV-QMS)
Drive development and continuous improvement of:
Quality Management Systems
Pharmacovigilance SOPs
Work Instructions
Compliance Frameworks
Support implementation of global quality standards.
Strengthen overall PV governance and oversight processes.
Compliance Metrics & KPI Management
Develop and monitor:
Quality KPIs
Compliance Metrics
Performance Indicators
Analyze trends and identify compliance risks.
Provide strategic recommendations based on data-driven insights.
Digital Transformation & Process Excellence
Support implementation of digital tools for:
Compliance Monitoring
CAPA Tracking
Inspection Readiness
Quality Reporting
Drive operational efficiency through automation and process optimization initiatives.
Subject Matter Expertise & Stakeholder Management
Serve as a Subject Matter Expert (SME) for:
Pharmacovigilance Compliance
Quality Systems
Regulatory Inspections
Audit Readiness
Provide guidance to headquarters and affiliate teams.
Represent Novo Nordisk in:
Internal Working Groups
Industry Forums
Regulatory Discussions
External Conferences
Training & Knowledge Sharing
Deliver PV compliance and inspection-readiness training.
Mentor colleagues across Global Patient Safety.
Promote a culture of compliance, quality, and continuous learning.
About the Department
The QPPV Office & PV Excellence Team operates within Novo Nordisk's Global Patient Safety organization and is responsible for ensuring global pharmacovigilance compliance, inspection readiness, and quality excellence.
The team collaborates closely with:
Qualified Person for Pharmacovigilance (QPPV)
Deputy QPPV
Global Patient Safety Leadership
Regulatory Affairs
Global Development
Quality Assurance
Legal & Compliance
Corporate Communications
Global Affiliates
Together, they ensure the highest standards of patient safety and regulatory compliance worldwide.
Required Qualifications
Education
Master's Degree or PhD in:
Pharmacy
Pharmacology
Life Sciences
Biotechnology
Biological Sciences
Related Healthcare Discipline
Preferred
Advanced certifications in:
Pharmacovigilance
Regulatory Affairs
Quality Management
GxP Compliance
Risk Management
Experience
Minimum 8+ years of experience in:
Pharmacovigilance
Drug Safety
PV Compliance
Safety Governance
Quality Systems
Regulatory Compliance
Strong Experience Required In
PV Audits
Regulatory Inspections
CAPA Management
PSMF Maintenance
Quality Oversight
Compliance Governance
Global Stakeholder Management
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Punjab | Rajpura |Andra Pradesh :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Madhya Pradesh :
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Bhubaneswar | Rourkela |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
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Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
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Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Indiana :
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Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
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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 :
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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 :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
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 | Renfrew | Australia | North York |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |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 :
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Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
Khulais | Jeddah | Najran | King Abdullah Economic City | Rabigh | Riyadh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
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