Grow with Us!
Are you looking for a dynamic company that offers daily challenges and opportunities? Look no further—Pharmalex is your career destination! 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.
Safety Report Development:
Lead the development, authorship, and tracking of Safety Reports (PSUR/RMP/ACOs) to ensure high-quality, regulatory-compliant documents. Manage logistics and distribution in a timely manner.
Operational Implementation:
Implement operational tasks related to safety writing and oversee service performance.
Mentorship:
Mentor team members, enabling them to work independently within established timelines, budgets, and quality standards.
Kick-off Meetings:
Organize kick-off meetings and prepare PSURs and RMPs according to client SOPs, ensuring medical cohesiveness and safety concern characterization.
Document Collaboration:
Collaborate with various teams to develop and author high-quality, compliant PSUR-PBRER, RMP, ACO, and DSUR documents.
Logistical Coordination:
Manage all logistical aspects related to the timely development of safety reports, ensuring that content meets client and Health Authority requirements.
Regulatory Updates:
Update the RMP in accordance with Health Authority requirements, ensuring alignment with other regulatory documents like the PSUR and CDS.
Consistency and Compliance:
Ensure regulatory compliance and consistency of RMP/PSUR/ACO sections and annexes. Track feedback from Health Authorities and implement necessary changes.
Training Development:
Develop and dispatch product-specific training materials for internal staff and third-party training.
Peer Review and Quality Control:
Conduct peer reviews, populate QC checklists, and address comments from stakeholders.
Health Authority Responses:
Prepare responses to Health Authority requests and formulate strategies for safety issues and integrated benefit-risk evaluations.
Experience:
Minimum of 5 years in aggregate report authoring (Innovators).
Qualifications:
B.Pharm, M.Pharm, BDS, or Pharm D.
If you are interested in this challenging opportunity at Pharmalex, we look forward to receiving your application. Please include your earliest possible starting date, any visa requirements, and salary expectations. Join us in shaping the future of pharmacovigilance.
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Punjab :
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Storrs |D.C :
Washington |Florida :
Coral Gables | Gainesville | Jacksonville | Naples | Orlando | Rueil-Malmaison | Tallahassee | Tampa | West Palm Beach |Georgia :
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Honolulu |Illinois :
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Bloomington | West Lafayette |Kansas :
Lawrence |LA :
Monroe | New Orleans |Maryland :
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Boston | Cambridge | Medford and Somerville | Rockland |Minnesota :
Minneapolis and St. Paul, Minnesota. |Missouri :
Fulton | St. Louis |New Jersey :
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Biddle | Buffalo | Hicksville | Ithaca | Morningside Heights | New York | Rensselaer | Syracuse |North Carolina :
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Chapel Hills | Durham | Morrisville | Philippines | Raleigh | Scottsdale |Ohio :
Columbus, |Oregon :
Bend | Corvallis | Eugene | Roseburg | Springfield |Pennsylvania :
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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 :
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Nedlands |Quebec :
Montreal |Republic of Colombia :
Bogota |Zagreb :
Zagreb |Republic of Egypt :
Cairo |United Kingdom :
Salt Lake City | Harlow | London |Jakarta :
Jakarta |Republic of Ireland :
Dublin | Limerick |Israel :
Netanya | Kfar Saba | Tel Aviv |Republic of Korea :
Seoul |Capital of Netherland :
Amsterdam |Noord Holland :
Haarlem |Remote :
Remote - Europe | Remote | Remote, USA | Switzerland |Makkah :
Jeddah | Rabigh | Najran | Khulais | Riyadh |Catalonia :
Barcelona |Republic of Thailand :
Bangkok |