Director – Medical Safety
Location: Bangalore, Karnataka / Kolkata, West Bengal, India
Company: IQVIA
Employment Type: Full-Time
Role Summary
The Director – Medical Safety provides strategic medical leadership and oversight for pharmacovigilance, medical monitoring, and clinical safety activities across clinical development programs. The role serves as a senior medical expert responsible for safety surveillance, medical review, risk assessment, benefit-risk evaluation, regulatory compliance, and client engagement within global clinical research programs.
This position requires a licensed physician with significant experience in clinical medicine, medical safety, pharmacovigilance, and pharmaceutical development. The Director will collaborate with sponsors, cross-functional teams, and regulatory stakeholders to ensure patient safety and compliance throughout the clinical trial lifecycle.
Key Responsibilities
Medical Safety Leadership
Provide strategic leadership for medical safety and pharmacovigilance activities across assigned clinical programs.
Serve as the medical safety expert for internal teams and external clients.
Support the development and execution of clinical safety strategies.
Ensure patient safety remains the primary focus throughout clinical development activities.
Medical Review & Safety Surveillance
Review and evaluate:
Serious Adverse Events (SAEs)
Adverse Events (AEs)
Suspected Unexpected Serious Adverse Reactions (SUSARs)
Safety Signals
Aggregate Safety Data
Perform medical assessment of safety events for:
Seriousness
Expectedness
Causality
Clinical Significance
Ensure timely identification and escalation of safety concerns.
Clinical Safety Monitoring
Provide ongoing medical oversight of clinical trials.
Monitor emerging safety trends and risk signals.
Contribute to safety monitoring plans and risk management strategies.
Support data review activities and interpretation of clinical safety findings.
Signal Detection & Risk Management
Lead safety signal detection and evaluation activities.
Conduct benefit-risk assessments for investigational and marketed products.
Develop risk mitigation strategies and recommendations.
Support Risk Management Plans (RMPs) and safety governance processes.
Regulatory Compliance & Safety Reporting
Ensure compliance with:
ICH Guidelines
Good Clinical Practice (GCP)
Global Pharmacovigilance Regulations
Local Regulatory Requirements
Support preparation and review of:
DSURs
PSURs/PBRERs
Safety Narratives
Regulatory Safety Reports
Participate in interactions with health authorities when required.
Clinical Trial Support
Provide medical safety input during:
Study Design
Protocol Development
Risk Assessments
Safety Monitoring Committees
Support clinical development teams throughout study execution.
Collaborate with Clinical Operations and Medical Monitoring teams.
Client & Stakeholder Management
Act as a trusted medical advisor to sponsors and clients.
Present safety findings and recommendations to senior stakeholders.
Build strong relationships with:
Pharmaceutical Sponsors
CRO Teams
Clinical Development Teams
Regulatory Stakeholders
Support business development and client engagement activities when needed.
Audit & Inspection Readiness
Support internal audits and regulatory inspections.
Ensure inspection readiness for assigned programs.
Participate in CAPA development and implementation.
Maintain compliance with company quality systems and procedures.
Cross-Functional Collaboration
Collaborate with:
Clinical Operations
Pharmacovigilance
Regulatory Affairs
Biostatistics
Data Management
Medical Writing
Ensure effective communication and alignment across project teams.
Provide expert medical guidance for complex safety issues.
Leadership & Mentorship
Mentor and support junior physicians and safety professionals.
Contribute to training and capability development initiatives.
Promote a culture of quality, compliance, and patient safety.
Support continuous improvement of medical safety processes.
Required Qualifications
Education
Medical Degree (MBBS/MD or equivalent) from an accredited and internationally recognized medical school.
Valid medical license (or equivalent) in the country/region of practice.
Experience
Minimum 5 years of clinical medical practice experience after obtaining medical degree.
AND
Minimum 5 years of experience in:
Medical Safety
Pharmacovigilance
Medical Monitoring
Clinical Development
Pharmaceutical Industry
OR
Equivalent combination of clinical and pharmaceutical industry experience.
Technical Skills & Expertise
Strong knowledge of:
Pharmacovigilance Principles
Medical Safety Surveillance
Clinical Trial Safety Monitoring
Risk Management
Signal Detection
Benefit-Risk Assessment
Comprehensive understanding of:
ICH-GCP
Global Regulatory Requirements
Drug Development Lifecycle
Clinical Research Processes
Experience with:
Safety Databases
Aggregate Safety Reporting
Regulatory Inspections
Medical Review Activities
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 :
Bilaspur | Eot Municipality | Raipur |Uttarakhand :
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 :
Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro | White Plains |Texas :
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 |California :
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 | Stanford | Stanton | St. Helena | Stockton | Sunnyvale | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |New York :
Albany | Biddle | Brooklyn | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |New Mexico :
Albuquerque | Farmington | Santa Fe | Tucumcari |Pennsylvania :
Ambler | Bethlehem | Collegeville | Harrisburg | Lancaster | Marietta | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Pottstown | Radnor | Sellersville | Southampton | Spring House | West Chester | Wyomissing |Alaska :
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 :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |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 | Newark | New Brunswick | 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 | Westfield | West Orange | Wharton | Whippany |Ohio :
Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Montgomery | Norwood | Oregoina | oxford | Waynesville |LA :
Baton Rouge | Monroe | New Orleans |Washington :
Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
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 :
Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Florida | Gainesville | Hollywood | Jacksonville | Maitland | Marsa | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Sarasota | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Idaho :
Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |North Caroline :
Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |Arizona :
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 :
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 :
Mississauga | Uxbridge | Renfrew | North York | Australia | Richmond Hill |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |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 :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |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 :
Be'Er Sheva | Kfar Saba | Netanya | Yavne | Tel Aviv |Remote :
Green Way | Ireland | Bishop | Riga | Milwaukee | Remote - Africa | Springville | Minnesota | Melbourne | Switzerland | Zaragoza | Leinster | Texas | Xzagreb | Remote - Europe | Castlebar | Regulatory Labeling Manager (NA and LATAM Only) | Hammond | Faridabad | Lousiana | Lenexa | Thailand | Victoria | Manipal | Remote - Middle East | Belgium | Nairobi | McFarland | Bountiful | Perth | Hungary | Slovakia | French | Tulsa | Medan | Blue Bell | Remote - South America (Latin Americal) |Republic of Colombia :
Bogota |Williamson :
Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
Riyadh | Najran | Jeddah | King Abdullah Economic City | Rabigh | Khulais |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 |
Sign in with Google
