Safety Manager

There is a permanent Safety Manager position available in Costa Mesa, CA

Overview:
1. Manage day-to-day operations of the Pharmacovigilance Department. Maintain communications with the all subsidiaries, licensees and distributors to timely identify, classify and report post-market adverse events (AEs) and pre-market serious adverse events (SAEs) associated with drug products.
2. Ensure compliance with pharmacovigilance regulations.
3. Develop and maintain a Drug Safety database with information from all drug products.
4. Conduct periodic audits of the Drug Safety database to proactively identify and bring to the attention of Pharmacovigilance Management regarding any irregularity, especially increases in the frequency and/or severity of adverse events associated with drug products.
5. Prepare and timely submit in conjunction with the Regulatory Affairs Department to the relevant Regulatory Authorities, expedited adverse event reports associated with drug products. Forward reports to the Regional (or local) Pharmacovigilance Centers for submission to the relevant regulatory authorities.
6. Prepare various Periodic Safety Reports for all Corporate drug products for submission to the Regulatory Authorities at the pre-established time intervals according to the regulations of each country where markets a drug product or conducts a clinical trial. Send copies of the report to the local Parmacovigilance Centers for submission to the relevant local Regulatory Authorities.
7. Assist in the organization and operation of Pharmacovigilance Centers worldwide. Collaborate in training staff assigned to Pharmacovigilance.
8. Periodically, review and update the Standard Operating Procedures for Drug Safety.




job Requirements


Please refer to the job description above.