Grow with Us!
Are you seeking a dynamic company that offers daily challenges and opportunities? Pharmalex is your ideal 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.
Locations: Noida & Hyderabad
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 efficiently.
Operational Implementation:
Implement operational tasks related to safety writing and oversee overall service performance.
Mentorship:
Mentor team members, empowering 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 accurate characterization of safety concerns.
Collaborative Development:
Work 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 the content meets client and Health Authority requirements.
Regulatory Compliance:
Update the RMP according to Health Authority requirements, ensuring alignment with other regulatory documents like the PSUR and CDS.
Consistency and Quality Control:
Ensure consistency and regulatory compliance of RMP/PSUR/ACO sections and annexes. Track feedback from Health Authorities and implement necessary changes.
Training Development:
Create and dispatch product-specific training materials for internal staff and third-party training.
Peer Review and Stakeholder Engagement:
Conduct peer reviews, populate QC checklists, and address comments from various stakeholders.
Health Authority Responses:
Prepare responses to Health Authority requests and formulate strategies for safety issues and integrated benefit-risk evaluations.
Experience:
Minimum of 2 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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Washington |Florida :
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Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |Denmark :
Copenhagen |Hungary :
Budapest |Istanbul :
Turkey |Serbia :
Belgrade |Switzerland :
Basel | Zurich |New South Wales :
Sydney |Queensland :
Queensland |Republic of Western Australia :
Nedlands |Hubei :
Wuhan |Republic of China :
Beijing |Tokiyo :
Tokyo | Osaka |Republic of Colombia :
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Zagreb |Republic of Egypt :
Cairo |United Kingdom :
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Seoul |Capital of Netherland :
Amsterdam |Remote :
Remote - Europe | Remote | Switzerland | Remote, USA |Makkah :
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Bangkok |