Director – Clinical Safety & Pharmacovigilance
Location: Noida (Noida Office)
Experience: 15–20 Years
Employment Type: Full-Time
Role Summary
The Director – Clinical Safety & Pharmacovigilance will provide strategic and operational leadership across pharmacovigilance and clinical safety activities for clinical trial and post-authorization products. This role is responsible for end-to-end oversight of safety surveillance, medical review, signal management, aggregate reporting, compliance, quality, and team leadership, ensuring adherence to global regulatory requirements, client agreements, and industry best practices.
Key Responsibilities
1. Strategic & Operational Leadership
Provide overall leadership and ownership of assigned pharmacovigilance and clinical safety projects.
Ensure effective planning, execution, and delivery of PV activities in line with client agreements, timelines, and quality expectations.
Act as a senior medical and scientific authority for safety-related decisions across products and therapeutic areas.
Support organizational growth by identifying process improvements, efficiencies, and best practices within pharmacovigilance operations.
2. Medical Review & Safety Assessment
Conduct and oversee medical review and assessment of Individual Case Safety Reports (ICSRs) from clinical trials and post-authorization sources.
Determine case reportability, seriousness, expectedness, and causality/relatedness.
Review case narratives, source documents, adverse event selection, and MedDRA coding to ensure medical accuracy and regulatory compliance.
Perform medical and scientific evaluation of safety data including ICSRs, signal reports, aggregate reports, and other safety information.
3. Signal Management & Risk Management
Lead and oversee signal detection, evaluation, and management activities for innovator and marketed products.
Implement and review signal detection methodologies in accordance with regulatory guidance.
Contribute to clinical safety strategy, risk management planning, and benefit-risk assessments.
Support ongoing safety surveillance and proactive risk identification across the product lifecycle.
4. Aggregate Reporting & Regulatory Deliverables
Oversee and provide medical review for aggregate safety reports, including DSURs, PSURs/PBRERs, and other regulatory submissions.
Ensure timely preparation, high-quality medical content, and compliance with global regulatory requirements.
Collaborate with cross-functional stakeholders to support regulatory submissions and regulatory responses.
5. Quality, Compliance & Documentation
Ensure compliance with applicable global regulations, guidelines, internal SOPs, and client-specific processes.
Maintain oversight of quality, compliance, and documentation across all assigned PV projects.
Author, review, and approve SOPs, work instructions, and other functional documents as assigned.
Represent the function during internal audits, client audits, and regulatory inspections.
6. Project & Stakeholder Management
Oversee project management activities, including workload planning, prioritization, and issue resolution.
Communicate effectively with internal and external stakeholders, including clients, vendors, and cross-functional teams.
Monitor project risks and escalate concerns related to quality, resourcing, or timelines to functional leadership.
7. People Leadership & Talent Development
Provide line management and leadership to assigned team members.
Guide, mentor, and develop team members to ensure high performance and professional growth.
Identify training needs and support ongoing learning and capability building within the function.
Monitor team workload and capacity, proactively addressing resourcing or performance challenges.
8. Additional Responsibilities
Perform other pharmacovigilance and clinical safety activities as assigned to meet evolving organizational and client needs.
Qualifications & Experience
Education
MBBS / MD (Mandatory)
Experience
15+ years of progressive experience in Pharmacovigilance and Clinical Safety, including:
Medical review of ICSRs (SAEs in clinical trials and post-marketing)
Signal detection and signal management
Preparation and medical review of DSURs and PSURs/PBRERs
Experience working with innovator molecules and multiple therapeutic areas.
Strong knowledge of global pharmacovigilance regulations and guidelines.
Proven leadership experience with strong decision-making and stakeholder management capabilities.
Excellent written and verbal communication skills.
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 :
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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 :
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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 :
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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 :
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Birmingham |Virginia :
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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 :
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 :
Australia | Richmond Hill | Uxbridge | North York | Renfrew | Mississauga |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 :
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 :
Kfar Saba | Be'Er Sheva | Tel Aviv | Yavne | Netanya |Remote :
Riga | Texas | Tulsa | Manipal | Leinster | Castlebar | Zaragoza | Xzagreb | Remote - Africa | Regulatory Labeling Manager (NA and LATAM Only) | Minnesota | Hungary | Nairobi | Faridabad | Remote - Europe | Slovakia | McFarland | Victoria | Melbourne | Lenexa | Perth | Ireland | Lousiana | Springville | Thailand | Remote - Middle East | Medan | Remote - South America (Latin Americal) | Hammond | Blue Bell | Green Way | Belgium | French | Bishop | Milwaukee | Bountiful | Switzerland |Republic of Colombia :
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Brentwood |Bucharest :
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Buenos Aires |Republic of Egypt :
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New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
King Abdullah Economic City | Rabigh | Jeddah | Riyadh | Khulais | Najran |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
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Sweden |Taipei :
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