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 advantageous. The role involves working in a hybrid model with rotational shifts.
Responsibilities
- Lead pharmacovigilance activities to ensure compliance with regulatory requirements and company standards.
- Oversee the collection assessment and reporting of adverse event data to maintain patient safety.
- Provide expert guidance on pharmacovigilance processes and ensure timely case processing.
- Collaborate with cross-functional teams to enhance safety operations and improve efficiency.
- Utilize MS Excel to analyze data and generate reports for stakeholders.
- Monitor trends in safety data and recommend actions to mitigate potential risks.
- Ensure accurate documentation and maintenance of pharmacovigilance records.
- Develop and implement strategies to optimize pharmacovigilance workflows.
- Conduct training sessions to enhance team knowledge and skills in safety operations.
- Support the development of pharmacovigilance policies and procedures.
- Engage with external partners to align on safety standards and practices.
- Contribute to the continuous improvement of pharmacovigilance systems and tools.
- Participate in audits and inspections to ensure compliance with industry regulations.
Qualifications
- Possess a strong background in Pharma Research & Development with a focus on safety.
- Demonstrate proficiency in MS Excel for data analysis and reporting.
- Experience in PV Case Processing is highly desirable.
- Familiarity with Pharmacovigilance & Safety Ops is a plus.
- Ability to work effectively in a hybrid model with rotational shifts.
- Strong analytical and problem-solving skills.
- Excellent communication and collaboration abilities.
Certifications Required
Certification in Pharmacovigilance or Drug Safety is preferred.