
Pharmacovigilance Manager Us
4 semanas atrás
Maintain a comprehensive understanding of FDA and regional regulations;
Support the US Local safety team by initiating, planning, executing, controlling, and closing projects, and communicate procedures and solutions effectively under tight deadlines;
Engage regularly withinternal and external stakeholders through proper channels to ensure accuracy, completeness, and issue resolution;
Ensure adherence to processes, and maintain relevant documentation;
Assess the impactof changes on safety requirements and coordinate with stakeholders for timely decisions;
Escalate unresolved issues following the established process;
Meet quality and turnaround time targets consistently;
Collaborate across functions to ensure smooth communication and delivery.Preferred qualifications:
Strong attention to detail and excellent communication skills in English (verbal & written);
Experience in team management and understanding of business principles;
University degreein Life Sciences or Pharmacy;
At least 10 yearsof experience in pharma/biotech, with 6 years in US FDA regulations and project management;
Personal initiative, responsibility, flexibility, and ability to handle multiple projects independently.Application instructions:
Please attach your resume in English.What we offer:
Health and life insuranceGympassSupport programs including psychological, legal, social, and financial assistancePartnerships with educational and training institutionsReimbursement for certificationsAccess to TCS Learning PortalInternational experience opportunitiesReferral bonuses and recognition programsTata Consultancy Services is an equal opportunity employer committed to diversity and inclusion. We welcome candidates from all backgrounds and encourage participation in our recruitment process.Join us and be part of an inclusive culture that respects individuality and promotes equity across gender, disability, LGBTQIA+, religion, race, and ethnicity.Additional detailsSeniority level:
Mid-Senior levelEmployment type:
Full-timeJob function:
ManagementIndustry:
Pharmaceutical Manufacturing#J-18808-Ljbffr
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