Director – Clinical Safety & Pharmacovigilance
Location: Noida, India
Employment Type: Full-Time
Experience Required: 15–20 Years
Role Summary
The Director – Clinical Safety & Pharmacovigilance provides strategic, medical, and operational leadership across global pharmacovigilance and clinical safety activities for clinical development and post-marketing products. This role is accountable for end-to-end oversight of safety surveillance, medical review, signal management, aggregate reporting, quality compliance, regulatory interactions, and team leadership.
The position serves as a senior medical authority responsible for ensuring patient safety, regulatory compliance, scientific integrity, and operational excellence across pharmacovigilance programs while driving organizational growth and client satisfaction.
Key Responsibilities
Strategic & Operational Leadership
Provide overall leadership and strategic direction for assigned Pharmacovigilance (PV) and Clinical Safety programs.
Ensure successful planning, execution, and delivery of safety activities in accordance with:
Client Agreements
Regulatory Requirements
Quality Standards
Project Timelines
Serve as a senior medical and scientific advisor for safety-related decisions.
Drive operational excellence, process optimization, and continuous improvement initiatives.
Contribute to business growth through innovation, best practices, and scalable pharmacovigilance solutions.
Medical Review & Safety Assessment
Conduct and oversee medical review of:
Individual Case Safety Reports (ICSRs)
Serious Adverse Events (SAEs)
Adverse Drug Reactions (ADRs)
Post-Marketing Safety Reports
Assess:
Case Reportability
Seriousness
Expectedness
Causality/Relatedness
Review:
Case Narratives
Source Documents
Adverse Event Selection
MedDRA Coding
Ensure medical accuracy, consistency, and compliance with global safety regulations.
Provide expert clinical interpretation of safety data across products and therapeutic areas.
Signal Detection, Signal Management & Risk Assessment
Lead signal detection and management activities for clinical and marketed products.
Implement and oversee signal detection methodologies aligned with global regulatory guidance.
Evaluate emerging safety concerns and determine appropriate escalation pathways.
Contribute to:
Benefit-Risk Assessments
Risk Management Plans (RMPs)
Safety Surveillance Strategies
Support proactive identification and mitigation of safety risks throughout the product lifecycle.
Aggregate Reporting & Regulatory Deliverables
Provide medical oversight and review of aggregate safety reports including:
Development Safety Update Reports (DSURs)
Periodic Safety Update Reports (PSURs)
Periodic Benefit-Risk Evaluation Reports (PBRERs)
Regulatory Safety Submissions
Ensure timely delivery of high-quality regulatory documents.
Collaborate with cross-functional teams to support regulatory filings and authority responses.
Maintain compliance with global reporting requirements and submission timelines.
Quality, Compliance & Inspection Readiness
Ensure compliance with:
Global Pharmacovigilance Regulations
ICH Guidelines
GVP Requirements
Internal SOPs
Client-Specific Procedures
Maintain oversight of quality systems and documentation across PV programs.
Author, review, approve, and maintain:
SOPs
Work Instructions
Safety Procedures
Functional Documents
Represent the pharmacovigilance function during:
Internal Audits
Client Audits
Regulatory Inspections
Ensure inspection readiness and timely CAPA implementation.
Project & Stakeholder Management
Lead project governance activities for assigned safety programs.
Manage:
Workload Planning
Resource Allocation
Risk Management
Issue Resolution
Build and maintain strong relationships with:
Clients
Regulatory Authorities
CROs
Vendors
Internal Stakeholders
Escalate quality, compliance, resource, and timeline risks appropriately.
People Leadership & Talent Development
Provide direct leadership and line management for pharmacovigilance teams.
Coach, mentor, and develop team members to achieve high performance.
Identify capability gaps and implement training and development plans.
Support succession planning and talent retention initiatives.
Foster a culture of accountability, collaboration, quality, and continuous learning.
Cross-Functional Collaboration
Collaborate with:
Clinical Development
Medical Affairs
Regulatory Affairs
Biostatistics
Data Management
Quality Assurance
Commercial Teams
Support integrated benefit-risk decision-making across development and marketed products.
Ensure alignment between safety strategy and organizational objectives.
Required Qualifications
Education
MBBS (Mandatory)
Preferred:
MD (Highly Preferred)
Additional specialization in Clinical Pharmacology, Internal Medicine, Oncology, Neurology, or related therapeutic areas is advantageous.
Experience
Minimum 15+ years of progressive experience in:
Pharmacovigilance
Drug Safety
Clinical Safety
Risk Management
Extensive experience in:
Medical Review of ICSRs
SAE Assessment
Signal Detection & Management
Aggregate Safety Reporting
Regulatory Safety Compliance
Experience supporting:
Clinical Trial Safety
Post-Marketing Pharmacovigilance
Innovator Molecules
Global Product Portfolios
Experience across multiple therapeutic areas is preferred.
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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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 :
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Birmingham |Virginia :
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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 :
Knoxville | Memphis | Nashville |Louisiana :
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 :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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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 :
Uxbridge | Richmond Hill | Australia | Renfrew | North York | Mississauga |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |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 :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Rho |Jakarta :
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Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
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Remote Korea |Republic of Korea :
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Green Way | Hammond | Minnesota | Hungary | Riga | Leinster | Xzagreb | Nairobi | Remote - Africa | Remote - Middle East | Regulatory Labeling Manager (NA and LATAM Only) | Melbourne | Slovakia | Bishop | French | Lousiana | Ireland | Blue Bell | Lenexa | Belgium | McFarland | Victoria | Perth | Medan | Remote - Europe | Thailand | Faridabad | Milwaukee | Remote - South America (Latin Americal) | Bountiful | Castlebar | Zaragoza | Switzerland | Texas | Tulsa | Springville | Manipal |Republic of Colombia :
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Ciudad de México | New Mexico |Dubai :
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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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Sweden |Taipei :
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