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.