Resume of Pharmacovigilance Analyst in Text Format
Phone: 9953776253 | Email: firstname.lastname@example.org|LinkedIn: linkedin.com/company/getsetresumes
PHARMACOVIGILANCE ANALYST - leveraging 12+ years of experience
Pharmacovigilance professional who excels at providing a complete range of industry-related processes including ICSR data input, medical safety and document analysis, its composition, formulation and execution of standard operating procedures, and corrective action plans. Ensures pharmacovigilance deliverables are of the highest quality and meet global regulatory reporting timelines. Provides extensive operational support for national pharmacovigilance activities.
- Well-versed with the knowledge of Converge Health Safety (CHS), PV RM software vendors, and products for assessment and selection.
- Provides operational support for global pharmacovigilance activities for the assigned departments.
- Ability to analyze internal and external trends and issues and take appropriate action.
- Demonstrated research experience in pharmacovigilance, clinical research, or regulatory affairs.
- Subject Matter Resource
- GCP compliance
- Quality Assurance
- Good Clinical Practice (GCP)
- Regulatory review
- Clinical Procedures
- Good Pharmacovigilance Practice(GVP)
- Continuous Improvement Process (CIP)
- Development Safety
- Update Reports
- Case Identification
- Periodic Safety
- Risk Management
Accenture, New Delhi Jan. 2017 – Present
Senior Pharmacovigilance Analyst
- Provide guidance and expertise on all aspects of clinical safety throughout the entire lifecycle of a product with special emphasis on ongoing evaluation of safety information during clinical development.
- Assess and interpret complex clinical safety data for signal detection and initiation of safety risk management activities including safety specification, PV planning and risk minimization and mitigation.
- Identify and implement all clinical standard-operating procedures in order to ensure GCP compliance.
- Serve as the senior clinical safety representative in the cross-functional development teams. Accenture’s clinical safety strategy for the national projects.
- Identify potential challenges, risks and roadblocks associated with the global safety domain and work as a leader in developing solutions to address them.
- Ensure safety alignment of the medical processes and standards as expected of manufacturers by internal and external stakeholders including regulators, governmental agencies, payers, physicians, patients and the general public.
Sun Pharmaceutical Industries Ltd., New Delhi | July. 2013 – Nov. 2016
- Oversaw the safety signal detection and medical signal evaluation process.
- Analyzed aggregate safety data and the production of key company documents such as DSURs (Development Safety Update Reports), PSURs (Periodic Safety Update Reports), and risk management plans relating to the safety of medicinal products, which are subject to regulatory review and discussion.
- Provided a safety role in facilitating reviews done by internal and external DMCs (Data Monitoring Committees) and in unbinding clinical data to protect ongoing study participants and complete timely.
- Ensured timely production of aggregate reports and answers to queries from Health Authorities according to consistent quality standards.
- Participated actively in the Continuous Improvement Process (CIP) targeted at continuous improvements of the quality of processes, methods, and communication.
- Reviewed and contributed to safety-relevant SOP and improvement of safety-relevant SOPs.
- Ensured regulatory agency inspection findings and internal audit findings relating to products of responsibility are addressed and resultant Corrective Action Plans (CAPA plans).
Cipla Ltd., New Delhi | July. 2011 – Jun. 2013
- Worked in coordination with the Safety Systems & Information Management and Strategic Alliance, Compliance & Training groups as part of a matrix team to support the Therapeutic Area business unit by ensuring that pre- and post-marketed products are adequately supported from a safety standpoint.
- Performed safety surveillance activities within a products team.
- Evaluated data, identified opportunities and risks, weighted alternatives, and presented analyses to Medical Director for review.
- Performed the first iteration of the review of the listing, and discuss issues with Medical Director.
- Performed review of the literature with appropriate documentation, identify case reports as well as new safety information, and alert Medical Directors, as to appropriate Risk Management/Post-Approval Commitments
- Followed up on safety-related post-approval regulatory commitments or assigned products
- Applied the basic principles of pharmacovigilance, activities associated with this discipline (e.g., signal detection report and analysis, signal identification, prioritization, signal management, aggregate reporting, periodic reporting compilation, analysis, etc.), and safety governance.
Cipla Ltd., New Delhi | July. 2010 – Jun. 2011
Pharmacovigilance - Intern
- Supported a wide range of moderate to the sometimes multifaceted scope and complex pharmacovigilance activities.
- Worked within established timeframes ensuring compliance with global and local procedures, policies, and guidelines.
- Contributed to the daily PV case processing activities, and safety reconciliation efforts, consisting of documentation and monitoring of safety information exchange.
- Provided support as required for project management activities including audit and inspection exposure and supported safety database initiatives.
Education – M.Pharm (Pharmacology) from Pune University, Pune | 2010
B. Pharm from Savitribai Phule Pune University, Pune | 2008
Languages Known: English, & Hindi
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