Pharmacovigilance Metrics Governance Principal Specialist
Company: Novo Nordisk
Location: Bangalore, Karnataka, India
Job Type: Full-Time
Department: PV Quality & Compliance Monitoring, Global Patient Safety (GPS)
Experience: 6+ Years
About the Role
Novo Nordisk is seeking a Pharmacovigilance Metrics Governance Principal Specialist to support the governance, monitoring, and continuous improvement of the global Pharmacovigilance (PV) system. The role focuses on quality and compliance metrics, governance processes, stakeholder collaboration, inspection readiness, and strategic improvement initiatives across Global Patient Safety (GPS), affiliates, and external partners.
The successful candidate will play a critical role in ensuring effective oversight of the global PV system while driving compliance, operational excellence, and continuous improvement initiatives.
Key Responsibilities
PV Metrics Governance & Compliance
Support the implementation and maintenance of the global PV metrics governance framework.
Monitor pharmacovigilance quality and compliance metrics across the global PV system.
Ensure adherence to internal quality standards and regulatory requirements.
Support oversight activities related to PV system performance and compliance.
Quality Monitoring & Reporting
Operationalize PV governance meetings and reporting processes.
Monitor key quality and compliance indicators (KPIs).
Facilitate issue escalation and risk identification processes.
Support periodic reporting and performance reviews.
Continuous Improvement
Drive process improvement initiatives across Global Patient Safety functions.
Harmonize PV quality and compliance processes with industry standards and internal requirements.
Identify opportunities to improve efficiency, quality, and governance effectiveness.
Foster a culture of continuous improvement and operational excellence.
Stakeholder Management
Build strong partnerships with:
Global Patient Safety Teams
Novo Nordisk Affiliates
R&D Functions
External Partners
Regulatory Authorities
Collaborate with stakeholders to align quality and compliance objectives.
Benchmark processes against industry best practices.
CAPA & Inspection Readiness
Support Corrective and Preventive Action (CAPA) activities.
Facilitate root cause investigations and compliance improvement plans.
Ensure audit and inspection readiness within the assigned area.
Participate in regulatory inspections and quality audits.
Governance & Strategic Support
Develop governance processes that improve collaboration across GPS and affiliate organizations.
Minimize process duplication and improve operational synergies.
Support strategic quality and compliance initiatives within Global Patient Safety.
Required Qualifications
Education
Bachelor's Degree in:
Pharmacy
Life Sciences
Biotechnology
Medicine
Related Healthcare Discipline
Experience
Minimum 6 years of experience in:
Pharmacovigilance Operations
Drug Safety
PV Compliance
PV Quality Management
Regulatory Compliance
Experience supporting global pharmacovigilance systems.
Experience participating in regulatory inspections and audits.
Required Skills
Pharmacovigilance (PV)
Drug Safety Operations
PV Compliance
PV Quality Management
GxP Compliance
CAPA Management
Quality Management Systems
Regulatory Inspections
Audit Readiness
Risk Management
Metrics & KPI Governance
Stakeholder Management
Process Improvement
Compliance Monitoring
Regulatory Intelligence
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 :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | parel | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Punjab :
amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Punjab | Rajpura |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Kakinada | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tamil nadu | Tiruchirappalli | tiruppur | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
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 :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Odisha :
Bhubaneswar | Rourkela |Chhattisgarh :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | Gangtok | New Delhi | PAN-India |Assam :
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 :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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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 | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
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Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
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Blacksburg | Charlottesville | Falls Church | Mechanicsville |Indiana :
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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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Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
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Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
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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 :
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Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
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Dún Laoghaire |Galway :
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Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
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Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
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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 :
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Montreal |Brussels :
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Zaventem |South America :
Peru | Argentina |Brazil :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
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Ho Chi Minh City |Italy :
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Oulu |Southwest Finland (Varsinais-Suomi) :
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Be'Er Sheva | Netanya | Yavne | Kfar Saba | Tel Aviv |Remote :
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New Mexico | Ciudad de México |Dubai :
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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 :
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