Architect (ATC)

Gurgaon, Haryana, India
Architect (ATC) - CREQ153980
Work Nature Experience Collaborate with Client Patient Safety Services teams, vendors, contractors, Client IT, and the development/support team to understand the risk or impact of upcoming changes Experience in handling Adverse Event from Spontaneous & Solicited Sources, Adverse Events from Non-intraventional studies & Serious Adverse events from interventional Clinical studies Experience in handling Individual Case Safety Report (ICSR) from Spontaneous & Solicited Sources Strong knowledge & experience in Pharmacovigilance projects. Awareness of any conditions or obligations and other commitments relating to safety or the safe use of the products. Applying key pharmacovigilance guidelines in the production of core documents Developing responses to regulatory agency (e.g. US FDA, UK MHRA, EU EMA) enquiries Provide safety contributions for regulatory agency interactions and/or when we are preparing to apply for a new licence to market a drug (known as product submission activities) Knowledge in adverse event reporting from clinical and post-marketed sources for Client products in accordance with pharmacovigilance regulations Knowledge in necessary quality, including correctness and completeness, of PV data submitted to the local regulatory authority Designing risk management activities for clinical trials and marketed use Prepare local Patient Risk Management Plans and maintain RMP tracker Ensures that local safety agreements are monitored and maintained Supports the ongoing business utilization of PS reporting, including troubleshooting problems and developing new reporting solutionsMinimum Requirements QualificationsBachelor's Degree or equivalent. 8 years or more of relevant experienceMinimum 4 years of BA with pharmacovigilance experienceWorking knowledge of Health Authority regulationsAbility to write, speak and lead in the English languageExcellent oral and written communications skills, business acumen with problem-solving and analytical skillsHave a deep understanding of the pharmaceutical industry, life sciences, and Patient safety Services.Business relationship management skills; ability to connect and engage with local management and stakeholders on areas of expertise.Organizing communications with multiple stakeholders and vendors.Ability to understand IT and business objectives.Ability to, set priorities, align stakeholder expectations, and develop and execute an associated action plan.Work with global virtual teams - aligning and adapting different work, culture and communication styles..Familiarity with Visualization Tools and CRM systems.Knowledge of SCRUM and SAFe agile practices
Primary Location
Gurgaon, Haryana, India
Job Type
Job Posting
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