Position Title: Medical Director - Pharmacovigilance
Location: Cambridge, MA
Job Type: Contract
Company Description
Katalyst Healthcares & Life Sciences specializes in contract research for clinical trials involving drugs, biologics, and medical devices. The company collaborates with university hospitals, pharmaceutical companies, and recruiting partners to provide expertise in Drug Safety, Pharmacovigilance, and Clinical Research.
Job Responsibilities
Developmental Program Support
Contribute to early and late-stage development programs as required.
Oversee signal detection and risk management activities for designated global/regional products.
Support Therapeutic Lead in safety-related initiatives.
Team Management
Provide line management for junior physicians and scientists.
Train and mentor Pharmacovigilance Physicians and Specialists.
Leadership Responsibilities
Serve as the Global Safety Lead (GSL) for compounds in development and marketed products.
Act as a companywide safety expert for assigned compounds.
Lead strategic safety programs and initiatives.
Regulatory Documentation and Negotiation
Develop and review regulatory documents such as safety summaries, MAAs, NDAs, and Integrated Analyses of Safety (IAS).
Negotiate safety-related matters with regulatory authorities.
Author executive summaries and risk/benefit profiles for compounds.
Global Pharmacovigilance Physician Activities
Review and oversee clinical and non-clinical safety data.
Provide input and sign-off on study protocols, statistical analysis plans (SAPs), clinical study reports, IBs, and regulatory submission documents.
Interact with external experts, regulatory agencies, and co-development partners.
Lead safety data analysis and prepare risk management plans and safety monitoring plans.
Direct safety procedures and develop safety exchange agreements for co-development projects.
Required Qualifications
Education
Qualified physician (License preferred, e.g., GMC registered).
Knowledge of epidemiology and statistics.
Experience
Minimum of 8 years in pharmacovigilance, clinical research, or clinical development.
2-3 years of clinical experience post-graduate training with substantial knowledge of general medicine.
Skills
Strong critical thinking, analytical, and decision-making skills.
Proficiency in Microsoft applications and statistical analysis tools.
Excellent written and verbal communication skills, including presenting to large internal and external groups.
Exceptional organizational and project management capabilities.
Additional Skills
Professional interpersonal skills to collaborate with senior executives, contractors, and colleagues.
Thorough analytical and numerical skills for multi-tasking and prioritizing.
Experience in leading cross-functional teams and regulatory negotiations.
Key Competencies
Strategic and proactive leadership in safety programs.
Expertise in safety signal detection and risk management.
Ability to train, mentor, and lead diverse teams effectively.
Andra Pradesh :
Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Visakhapatnam |Assam :
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Ahmedabad | Baroda | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
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B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram |Madhya Pradesh :
Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane | Vikhroli |Odisha :
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Rangpo |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |Uttarakhand :
Dehradun | Nainital | Rishikesh |West Bengal :
Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
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Chandler | Kingman | Lake Havasu City | Peridot | Phoenix | Tempe | Tucson | Yuma |Arkansas :
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Alameda | Albion | Arcata | Berkeley | Brisbane | Burney | California | Carlsbad | Crescent City | Davis | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Morgan Hill | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redding | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | Stanford | Stanton | Temecula | Thousand Oaks | Vallejo | West Valley City | Whittier | Willits |Colorado :
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Boca Raton | Clearwater | Coral Gables | Coral Springs | Daytona Beach | Gainesville | Jacksonville | Maitland | Miami | Naples | Orlando | Pembroke Pines | Port St. Lucie | Rueil-Malmaison | Stuart | Tallahassee | Tampa | West Palm Beach |Georgia :
Atlanta | Rome |Hawaii :
Hilo | Honolulu |Idaho :
Boise |Illinois :
Abbott Park | Champaign | Chicago | Deerfield | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Indiana :
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Frank Scottile Blvd |LA :
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Bangor | Brewer |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake |Minnesota :
Duluth | Eden Prairie | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | St.Paul |Missouri :
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Farmington | Santa Fe | Tucumcari |New York :
Albany | Biddle | Buffalo | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Rensselaer | Syracuse | Utica |North Carolina :
Concord | Lumberton | North Carolina |North Caroline :
Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Sanford | Scottsdale |North Dakota :
Dickinson |northeastern :
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Cincinnati | Cleveland | Columbus, | Erie | Macedonia | oxford |Oklahoma :
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Bend | Coquille | Corvallis | Eugene | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Pennsylvania :
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Lisbon | Portugal |Puerto Rico :
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Mexico |South Carolina :
Charleston |Tennessee :
Memphis | Nashville |Texas :
Abilene | Arlington | Austin | Brenham | Bulverde | Corpus Christi | Corsicana | Dallas | Fort Worth | Houston | Lakeway | Longview | Plano | Richardson | San Antonio | Tyler | Waco |United states :
fairmont | Georgia | United States |United States :
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Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
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Cairo |South Yorkshire :
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Lyon | Paris |Attica :
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Jakarta |Israel :
Tel Aviv | Kfar Saba | Be'Er Sheva | Netanya |Italy :
Italy |Lombardy :
Rho |Japan :
Japan |Tokyo :
Otemachi |Kazakhstan :
Almaty |Remote Korea :
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Seoul |Kuala Lumpur :
Kuala Lumpur |Mexico :
Ciudad de México |Cebu Province :
Cebu City |Philippines :
Manila |Mazovia :
Warsaw |Remote :
Remote - Europe | Remote - Middle East | Remote, USA | Remote | Switzerland |Bucharest :
Bucharest |Makkah :
Jeddah | Najran | Riyadh | Rabigh | Khulais |Nišava District :
Niš |Singapore :
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Midrand |Brazil :
Sao paulo |South America :
Argentina |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
Bangkok |Kyiv Oblast :
Kyiv |Dubai :
Dubai |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |