Position: Risk Evaluation and Mitigation Strategy (REMS) Specialist/Manager (Remote)
Location: Stamford, CT (Remote)
Assignment Description:
A deep appreciation of Drug safety, FDA REMS program requirements and key processes.
Experience in setting up REMS program with exposure to multiple therapy areas.
Experience collaborating with PMO and other RPC members of the consortium REMS on various topics.
Develop and gather the material, and guide the client team for the future REMS Inspections.
Attend and actively participate on various REMS Consortium meetings and sub teams.
Experience investigating, documenting, and resolving instances of non-compliance by patients, prescribers, and pharmacies.
Knowledge and some experience in design and implementation of REMS systems and tools.
Strong foundations in drug safety and pharmacovigilance principles.
Should have sound knowledge in Risk Evaluation and Mitigation Strategy (REMS), REMS Assessment reports, RMM tracking with REMS support as per the Regulations and Standards Operating Procedures (SOPs)
Knowledge of Stakeholder workflows including but not limited to EHRs, Pharmacy, REMS administrators, patients, and wholesalers.
Knowledge on current FDA regulations and guidance regarding REMS, including Medication Guides, ETASU, Shared REMS, Survey Methodologies, etc. Should have awareness of changes to/ new industry regulations Have knowledge of preparation of aggregate safety reports (e.g., DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and EU Risk Management Plans (RMPs) Drug safety, pharmacovigilance and/or risk management industry experience in both the investigational and post-approval environments.
Knowledge and some experience in the preparation and authoring of aggregate safety reports, RMPs, and RSI.
Deep understanding of global pharmacovigilance regulations, guidelines, and best practices.
Good understanding of SDLC requirements and 21 CFR Part 11, GxP guidelines
Analyze requirements specified by FDA pertaining to REMS and other patient safety/risk management programs.
Document requirement specifications for the REMS system.
Act as a subject matter expert on REMS to various program participants especially the technology teams.
Coordinate with users of the REMS system to ensure that their needs are appropriately addressed through the system implementation.
Contribute to resolving any issues pertaining to implementation of REMS business requirements.
Provide regular updates to the project manager and highlight risks in a timely manner.
Facilitate internal review of REMS Assessment Reports and communicates the findings/observations back to REMS PMO.
Assist with the development and implementation of risk management strategies, including REMS (Risk Evaluation and Mitigation Strategies) to minimize the potential safety risks.
Review cumulative data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information. Recommend enhancements to existing risk management/mitigation strategies and assist with the development of new risk management/mitigation strategies.
At least 5 years of experience in pharma (preferably drug safety, risk management, or epidemiology) with at least 2 years of direct experience in REMS.
Medical/scientific background, epidemiology preferred.
Summary of Work:
Should have sound knowledge in Risk Evaluation and Mitigation Strategy (REMS), REMS Assessment reports, RMM tracking with REMS support as per the Regulations and Standards Operating Procedures (SOPs)
FDA Regulation knowledge
5 years of experience in pharma (preferably drug safety, risk management, or epidemiology) with at least 2 years of direct experience in REMS.
Must have experience in handling REMS audit
Must have experience in direct REMS involvement
Subject matter expert on REMS
Top Qualities: Vendor insight, PMO's, direct knowledge with preparing for inspections.
Team Structure: Reports to hiring manager, will also work with 1 physician and 1 scientist on a day-to-day basis. Will also be cross-functional working with Medical Affairs and Quality departments.
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Dibrugarh | Diburghar | Guwahati |Bihar :
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Delhi | India | New Delhi | PAN-India |Goa :
Goa | Panaji |Gujarat :
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Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram |Madhya Pradesh :
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Ambernath | Amravati | Aurangabad | Jalgaon | Kolhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane |PAN-India :
Panjab :
Punjab :
Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Jaipur | Pilani | Udaipur |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 :
Anchorage | Barrow | Bethel | Juneau | Wrangell |Arizona :
Chandler | Kingman | Lake Havasu City | Peridot | Phoenix | Tempe | Tucson | Yuma |California :
Brisbane | Crescent City | Davis | El Monte | Emeryville | Foster City | Fremont | Irvine | La Jolla | Los Angeles | Martinez | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | Stanford | Vallejo | West Valley City | Whittier | Willits |Colorado :
Denver |Connecticut :
Groton | Storrs |D.C :
Washington |Florida :
Clearwater | Coral Gables | Gainesville | Jacksonville | Naples | Orlando | Rueil-Malmaison | Tallahassee | Tampa | West Palm Beach |Georgia :
Atlanta |Hawaii :
Honolulu |Illinois :
Abbott Park | Champaign | Chicago | Deerfield | Lombard | Naperville | Round Lake |Indiana :
Bloomington | West Lafayette |Kansas :
Lawrence |LA :
Monroe | New Orleans |Maryland :
Baltimore | Elkridge | Gaithersburg | Rockville |Massachusetts :
Boston | Cambridge | Devens | Medford and Somerville | Rockland |Michigan :
Detroit |Minnesota :
Minneapolis and St. Paul, Minnesota. |Missouri :
Fulton | St. Louis |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Mount Arlington | New Brunswick | Newark | 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 | West Orange | Westfield | Wharton | Whippany |New York :
Biddle | Buffalo | Hicksville | Ithaca | Morningside Heights | New York | Rensselaer | Syracuse |North Carolina :
Concord |North Caroline :
Chapel Hills | Durham | Morrisville | Philippines | Raleigh | Scottsdale |Ohio :
Cincinnati | Cleveland | Columbus, |Oregon :
Bend | Corvallis | Eugene | Roseburg | Springfield |Pennsylvania :
Ambler | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | West Chester | Wyomissing |Portugal :
Lisbon |Puerto Rico :
San Juan |Republic of Mexico :
Mexico |Tennessee :
Nashville |Texas :
Austin | Dallas | Houston | Richardson |Virginia :
Blacksburg | Charlottesville | Falls Church |Washington :
Goldendale | Pullman | Seattle |WI :
Madison | Wausau |Wisconsin :
Wyoming :
Cokeville |Baden-Wurttemberg :
Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |Hesse :
Marburg |Hessen :
Frankfurt |Lower Saxony :
Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Mainz |Rotherbaum :
Hamburg |Saarland :
Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |Denmark :
Copenhagen |Hungary :
Budapest |Istanbul :
Turkey |Serbia :
Belgrade |Switzerland :
Basel | Zurich |Hubei :
Wuhan |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |New South Wales :
Sydney |Queensland :
Queensland |Republic of Western Australia :
Nedlands |Ontario :
Richmond Hill | North York |Quebec :
Montreal |Republic of Colombia :
Bogota |Zagreb :
Zagreb |Republic of Egypt :
Cairo |United Kingdom :
London | Harlow | Salt Lake City |Jakarta :
Jakarta |County Dublin :
Swords |Republic of Ireland :
Limerick | Waterford | Dublin |Israel :
Tel Aviv | Kfar Saba | Be'Er Sheva | Netanya |Republic of Korea :
Seoul |Capital of Netherland :
Amsterdam |Noord Holland :
Haarlem |Remote :
Remote | Remote - Europe | Remote, USA | Switzerland |Makkah :
Riyadh | Jeddah | Khulais | Rabigh | Najran |Catalonia :
Barcelona |Republic of Thailand :
Bangkok |