Leads safety operation function to ensure drug safety deliverable is compliant to the time and quality requirements for safety reporting, in accordance with regulatory requirements and standard operating procedures.
1. Manage collection/ processing/documentation/ reporting of all adverse event reports to CSPV for products from clinical trials, non-interventional studies, literature, Spontaneous Reports, etc.
2. Manage reporting/submission/distribution of safety reports /information (e.g. SAE, SUSAR,) to Local Health Authorities and/or clinical operations.
3. Oversees safety service vendors to ensure vendor’s output is consistent with company needs, expectations, and contractual obligations.
4. Interact and exchange relevant safety information with third-party contractor, if applicable.
5. Develop, update and implement local ICSR related procedures to ensure compliance with Patient Safety global procedures and national requirements.
6. Perform reconciliation with other departments for potential AEs resulting from medical inquiries, quality related complaints and other sources.
7. Management and maintenance of Patient Safety databases.
8. Prepare reports on ICSR compliance in a timely manner
9. Support on periodic safety reports related activities
10. Establishes and maintains effective relationships with partners regarding collaboration, project execution, and process-related issues.
11. Supports quality assurance activities for the consistency and quality of the pharmacovigilance process.
12. Contributes to audit/inspection readiness for pharmacovigilance activities.
13. Involve in identification and selection of candidates for the relevant Drug Safety & Pharmacovigilance positions. Provide mentoring and training to the department and within the company as needed.
1. At least 5 years relevant pharmaceutical industry experience in pharmacovigilance/drug safety
2. Medical, pharmaceutical, epidemiology or related background with bachelor/master degree
3. Advanced Knowledge of national and international regulations for pharmacovigilance
4. Demonstrated experience in safety operation project management
5. Excellent CRO/vendors management skills or CRO working experience is preferred
6. Fluent in both written and spoken English language
7. Good interpersonal skills and multitasks management ability.