Grow with Us!
Are you seeking a dynamic company that offers daily challenges and opportunities? Look no further—Pharmalex is your next career move! As one of the leading service providers in the pharmaceutical industry globally, Pharmalex specializes in all aspects of drug and medical device approvals, market development, and effective product maintenance.
This is a remote position for candidates already based in Poland with proven experience in local pharmacovigilance activities.
Primary Contact:
Act as the main point of contact for Pharmacovigilance (PV) with the Competent Authority in the territory, maintaining 24/7 availability if legally required.
Interface Management:
Serve as the liaison between the EU-QPPV/Global PV team and local regulatory authorities.
Local PV System Management:
Set up and manage the local pharmacovigilance system, including literature searches, ICSR management, and PV intelligence screening.
PSMF and Data Collection:
Maintain the local Pharmacovigilance System Master File (PSMF) and organize local data collection.
Signal Detection and Reporting:
Conduct local signal detection, adapt and submit PSURs and RMPs, and implement risk minimization measures.
Review and Support:
Review materials related to post-authorization safety and provide integrated first-level medical information and PQC support.
Audit Participation:
Participate in PV-related audits and inspections and attend regular project meetings.
Monthly Reporting:
Provide monthly reports on the status of the local PV system.
Training:
Ensure PV training for affiliate employees, service providers, and third parties.
Education:
University degree in Medicine, Pharmacy, or Life Sciences.
Experience:
Several years of experience and in-depth knowledge in pharmacovigilance.
Regulatory Knowledge:
Familiarity with relevant global and local legislative guidelines and detailed knowledge of SOPs.
Operational Expertise:
Experience in all operational tasks performed by the pharmacovigilance department.
Organizational Skills:
Ability to manage multiple tasks simultaneously and coordinate personnel resources effectively.
Adaptability:
Capable of adjusting rapidly to new and challenging situations.
Problem-Solving Skills:
Strong analytical abilities to identify and solve problems.
Team Player:
Autonomous, concentrated, and capable of high-quality work, with a strong sense of responsibility.
Language Skills:
Proficiency in Polish is required, along with a very good command of English.
If you are interested in joining the Pharmalex team for this exciting opportunity, please submit your application, including your earliest possible starting date, any visa requirements, and salary expectations. We look forward to hearing from you!
Note: Agencies should contact us only with prior agreement regarding this specific job opportunity.
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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 :
Baton Rouge | Monroe | New Orleans |Louisiana :
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Bangor | Brewer |Maryland :
Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro |Massachusetts :
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 :
Fulton | Milan | St. Louis |Nebraska :
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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 | Rocky Mount | Sanford | Scottsdale |North Dakota :
Dickinson |northeastern :
New Hampshire |Ohio :
Cincinnati | Cleveland | Columbus, | Dayton | Erie | Macedonia | Oregoina | oxford | Waynesville |Oklahoma :
Oklahoma City |Oregon :
Bend | Coquille | Corvallis | Eugene | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Pennsylvania :
Ambler | Collegeville | Harrisburg | Lancaster | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Radnor | Spring House | West Chester | Wyomissing |Portugal :
Lisbon | Portugal |Puerto Rico :
San Juan |Republic of Mexico :
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 :
Hawai | Sylmar |Virginia :
Blacksburg | Charlottesville | Falls Church |Washington :
Bellevue | Bothell | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Vancouver |WI :
Madison | Wausau |Wisconsin :
Portage |Wyoming :
Big Piney | Cokeville |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |Germany :
Germany | GErmany |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Lower Saxony :
Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Rotherbaum :
Hamburg |Saarland :
Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |BULGARIA :
Bulgaria |Denmark :
Copenhagen | Denmark |Europe :
Latvia | Leuven | Poland | Spain |Finland :
Finland |Hungary :
Budapest |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Serbia :
Belgrade | Serbia |Switzerland :
Basel | Zurich |China :
China |Hubei :
Wuhan |Liaoning :
Dalian |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Cork :
Ringaskiddy |County Dublin :
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Ballina | Sydney |Queensland :
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Remote Australia |Republic of Western Australia :
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Vienna |Antwerp :
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Brussels |Bosnia and Herzegovina :
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Sofia |Canada :
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Montreal |Chile :
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Croatia |Zagreb :
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Prague |Republic of Egypt :
Cairo |South Yorkshire :
Sheffield |United Kingdom :
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North Ostrobothnia :
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Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Tel Aviv | Kfar Saba | Be'Er Sheva | Netanya |Italy :
Italy |Lombardy :
Rho |Japan :
Japan |Tokyo :
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Almaty |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kuala Lumpur :
Kuala Lumpur |Mexico :
Ciudad de México |Cebu Province :
Cebu City |Philippines :
Manila |Mazovia :
Warsaw |Remote :
Switzerland | Remote, USA | Remote - Europe | Remote | Remote - Middle East |Bucharest :
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Niš |Singapore :
Singapore |South Africa :
Midrand |Brazil :
Sao paulo |South America :
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Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
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Brentwood |Republic of Thailand :
Bangkok |Kyiv Oblast :
Kyiv |Dubai :
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Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |