Live opening · Posted 7 days ago
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Job Summary
We are seeking an experienced professional for the role of TL-Pharmacovigilance with 6 to 9 years of experience. The ideal candidate will have expertise in Pharma Research & Development and proficiency in MS Excel. Experience in PV Case Processing and Pharmacovigilance & Safety Ops is a plus. The role involves a hybrid work model with rotational shifts.
Responsibilities
Oversee the pharmacovigilance activities to ensure compliance with regulatory requirements and company standards.
Provide expertise in Pharma Research & Development to enhance the quality and efficiency of safety operations.
Utilize MS Excel to analyze and report pharmacovigilance data accurately and efficiently.
Coordinate with cross-functional teams to ensure seamless integration of safety data into the overall drug development process.
Monitor and evaluate adverse event reports to identify potential safety signals and trends.
Ensure timely and accurate case processing in accordance with standard operating procedures.
Collaborate with global teams to harmonize pharmacovigilance practices and share best practices.
Develop and implement safety monitoring plans to proactively manage potential risks.
Conduct regular audits and assessments to ensure compliance with pharmacovigilance regulations.
Provide training and guidance to junior staff on pharmacovigilance processes and procedures.
Support the preparation of safety reports and regulatory submissions.
Engage in continuous improvement initiatives to enhance pharmacovigilance operations.
Maintain up-to-date knowledge of pharmacovigilance regulations and industry trends.
Qualifications
Demonstrate strong expertise in Pharma Research & Development with a focus on safety operations.
Exhibit proficiency in MS Excel for data analysis and reporting.
Possess experience in PV Case Processing and Pharmacovigilance & Safety Ops as a valuable asset.
Show ability to work effectively in a hybrid work model with rotational shifts.
Display excellent communication and collaboration skills to work with cross-functional teams.
Have a keen eye for detail and a proactive approach to identifying and managing risks.
Certifications Required
Certified Pharmacovigilance Professional (CPP) or equivalent certification preferred.
Work arrangement
Hybrid
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