Job Responsibilities:
Report Preparation: Prepare various aggregate reports, including Periodic Benefit Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), Addendum to Clinical Overviews (ACOs), Addendum PSURs, PSUR Line Listings, and US Periodic Adverse Drug Experience Reports (PADERs). Ensure adherence to client conventions and regulatory requirements.
Quality Assurance: Conduct quality checks on aggregate reports to ensure accuracy and compliance.
Signal Detection and Analysis: Perform signal detection-related analyses and prepare reports, including cumulative analyses, issue event analyses, Signal Evaluation Reports, and Drug Safety Reports. Review published literature and case listings.
Medical Vigilance: Monitor important or designated medical events and interact with client personnel to discuss potential signals and issues detected with products.
Risk Management: Support the preparation and maintenance of Risk Management Plans (RMPs). Follow up with clients to obtain incomplete or missing information, resolve issues, and clarify details.
Medical Review: Perform medical reviews of individual case safety reports (ICSRs) and narratives for Clinical Study Reports (CSRs). Provide medical advice to drug safety scientists to assist with the processing of ICSRs and CSR narratives.
Knowledge Maintenance: Maintain an excellent knowledge of the adverse event safety profiles of assigned drugs, labeling documents, and client guidelines and Standard Operating Procedures (SOPs). Stay updated on global regulatory reporting obligations and ensure compliance with internal and regulatory timelines for report submissions.
Record Keeping: Maintain records in compliance with guidelines and SOPs.
Minimum Qualifications:
Education: Degree in Medicine (MBBS) or a post-graduate qualification (MD), preferably in a clinical branch.
Skills:
Note: Candidates with qualifications in Ayurvedic, homeopathic, veterinary medicine, alternative medical streams, or life sciences backgrounds need not apply.
Andra Pradesh :
Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Tirupathi | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
Goa | Panaji |Gujarat :
Ahmedabad | Baroda | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
Ambala | Hisar | Kurukshetra | Panchkula | Rohtak |Himachal Pradesh :
Solan |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram |Madhya Pradesh :
Dewas | Gwalior | Indore |Maharashtra :
Ambernath | Amravati | Aurangabad | Jalgaon | Kolhapur | Mumbai | Nagpur | 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 |Arizona :
Chandler | Tempe | Tucson |California :
Brisbane | Davis | Emeryville | Foster City | Fremont | Irvine | La Jolla | Los Angeles | Mountain View | Nevada | Pasadena | Pleasanton | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | Santa Clara | Santa Monica | Simi Valley | Stanford | West Valley City |Colorado :
Denver |Connecticut :
Storrs |D.C :
Washington |Florida :
Coral Gables | Gainesville | Jacksonville | Orlando | Rueil-Malmaison | Tallahassee | West Palm Beach |Georgia :
Atlanta |Hawaii :
Honolulu |Illinois :
Abbott Park | Champaign | Chicago | Deerfield | Lombard | Naperville |Indiana :
Bloomington | West Lafayette |Kansas :
Lawrence |Maryland :
Baltimore | Rockville |Massachusetts :
Boston | Cambridge | Medford and Somerville | Rockland |Minnesota :
Minneapolis and St. Paul, Minnesota. |Missouri :
Fulton | St. Louis |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Indianapolis | 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 | Ithaca | Morningside Heights | New York | Syracuse |North Caroline :
Chapel Hills | Durham | Morrisville | Raleigh | Scottsdale |Ohio :
Columbus, |Pennsylvania :
Ambler | Philadelphia | Pittsburgh |Puerto Rico :
San Juan |Republic of Mexico :
Mexico |Tennessee :
Nashville |Texas :
Austin | Dallas | Houston | Richardson |Virginia :
Blacksburg | Charlottesville | Falls Church |Washington :
Pullman | Seattle |WI :
Madison | Wausau |Wisconsin :
Baden-Wurttemberg :
Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen |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 |New South Wales :
Sydney |Queensland :
Queensland |Republic of Western Australia :
Nedlands |Republic of China :
Beijing |Tokiyo :
Tokyo | Osaka |Republic of Colombia :
Bogota |Zagreb :
Zagreb |Republic of Egypt :
Cairo |United Kingdom :
London | Salt Lake City |Republic of Ireland :
Limerick | Dublin |Republic of Korea :
Seoul |Capital of Netherland :
Amsterdam |Remote :
Remote - Europe | Remote | Switzerland | Remote, USA |Makkah :
Jeddah | Najran | Rabigh | Riyadh | Khulais |Catalonia :
Barcelona |Republic of Thailand :
Bangkok |