Performs day-to-day Pharmacovigilance (PV) activities performed within a highly regulated environment and driven by strict timelines. Pharmacovigilance activities include but are not limited to collection, monitoring, assessment, evaluation, research and tracking of safety information. Coordinates and
performs Pharmacovigilance activities such as data entry, coding and assessment of adverse events, case review, follow-up, tracking of reports, and regulatory reporting activities. Effectively collaborates with various parties such as: project team members, client contacts, investigators, and adverse event/
reporters, and third party vendors. May assist in the preparation of departmental and project-specific procedures and processes, prepare for and attend audits, kick-off and investigator meetings.
Essential Functions
Performs day-to-day PV activities. May participate in on-call duties for specific projects to ensure 24-hr coverage for intake of cases from investigative sites.
Reviews regulatory/pharmacovigilance publications and information sources to keep updated on current regulations, practices, procedures and proposals.
Maintains medical understanding of applicable therapeutic area and disease
states.
Reviews cases entered for quality, consistency and accuracy, including review of peer reports.
Prepares and maintains regulatory safety reports.
Assists with routine project implementation and coordination (e.g., Clinical Trials, Endpoint Assessment Committee/Data Safety Monitoring Committee), including presentations at client/investigator meetings, and review of metrics and budget considerations. Mentors less experienced staff.
Education and Experience:
Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
General understanding of pathophysiology and the disease process
Detailed knowledge of relevant therapeutic areas as required for processing AEs
Strong critical thinking and problem solving skills
Good oral and written communication skills including paraphrasing skills
Good command of English and ability to translate information into local language where required
Computer literate with the ability to work within multiple databases
Previous exposure to Microsoft Office packages (including Outlook, Word, and Excel)
Understanding the importance of and compliance with procedural documents and regulations
Ability to manage and prioritize a variety of tasks and meet strict deadlines with limited supervision
Strong attention to detail
Ability to maintain a positive and professional demeanor in challenging circumstances
Ability to work effectively within a team to attain a shared goal
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 | Khandwa | Khargone | Ujjain |Maharashtra :
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 :
Storrs |D.C :
Washington |Florida :
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 | 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 | 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 :
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 |Quebec :
Montreal |Republic of Colombia :
Bogota |Zagreb :
Zagreb |Republic of Egypt :
Cairo |United Kingdom :
Harlow | London | Salt Lake City |Jakarta :
Jakarta |Republic of Ireland :
Limerick | Dublin |Israel :
Netanya | Tel Aviv | Kfar Saba |Republic of Korea :
Seoul |Capital of Netherland :
Amsterdam |Remote :
Remote, USA | Switzerland | Remote - Europe | Remote |Makkah :
Khulais | Rabigh | Jeddah | Riyadh | Najran |Catalonia :
Barcelona |Republic of Thailand :
Bangkok |