TL-Pharmacovigilance

Job Summary

Data - Join our dynamic team as a Pharmacovigilance Specialist where you will play a crucial role in ensuring the safety and efficacy of pharmaceutical products. With a focus on Pharma Research and Development you will contribute to the monitoring and reporting of drug safety data. This hybrid role offers a rotational shift schedule providing flexibility and the opportunity to make a significant impact on public health.

Responsibilities

• Monitor and evaluate adverse event reports to ensure compliance with regulatory requirements and company standards.
• Collaborate with cross-functional teams to analyze safety data and identify potential safety signals.
• Prepare and submit aggregate reports such as PSURs to regulatory authorities in a timely manner.
• Conduct thorough research and development activities to support the safety profile of pharmaceutical products.
• Utilize your expertise in Pharmacovigilance and Safety Operations to enhance drug safety monitoring processes.
• Provide technical guidance and support to team members in the analysis and interpretation of safety data.
• Develop and implement strategies to improve the efficiency and effectiveness of safety reporting systems.
• Ensure accurate documentation and maintenance of safety data in compliance with regulatory guidelines.
• Participate in the development and review of standard operating procedures related to pharmacovigilance activities.
• Collaborate with stakeholders to address safety-related inquiries and provide expert advice.
• Contribute to the continuous improvement of pharmacovigilance processes and systems.
• Support the training and development of team members in pharmacovigilance practices.
• Engage in regular communication with regulatory authorities to ensure alignment on safety reporting requirements.

Qualifications

• Possess a strong background in Pharma Research and Development with a minimum of 4 years of experience.
• Demonstrate expertise in Aggregate (PSUR) reporting and Pharmacovigilance and Safety Operations.
• Exhibit proficiency in analyzing and interpreting complex safety data.
• Display excellent communication and collaboration skills to work effectively in a hybrid work model.
• Show adaptability to rotational shifts and a commitment to maintaining high standards of safety reporting.
• Hold a relevant certification in Pharmacovigilance or a related field.

Certifications Required

Certified Pharmacovigilance Professional (CPP) or equivalent certification.