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Headquarters: Building F2, 88 Kechuang, 6th St., Beijing , China
Beijing Office : Suite 2105, Building T2, Dazu Square, Beijing , China
Shanghai Office: 595 North Caoxi Road Building A Suite 6009 , Shanghai China
Boston Office: 99 Hayden Ave, Lexington, MA 02421, US
Tel: +86 010-56315466
Fax: +86 010-56315314
1 Manage outsourced safety-related functions, including safety receipt, adverse event data entry, coding and assessment of adverse events, regulatory submissions, SAE reconciliation, if needed.
2 Develop SOP and guidelines and conduct training.
3 Establish regulatory reporting requirements matrices per requirements.
4 Establish and maintain data entry guidelines and provide ongoing training to staff to ensure adherence to the guidelines.
5 Assist in managing the safety database activities, including liaison to the safety database vendor, support for issue resolution, initiation of change control, as applicable, and training.
6 Perform case review, adverse event coding review, tracking of reports, and regulatory reporting activities to comply with protocol and regulatory specific requirements.
7 Prepare for expedited reporting of SAEs, including support the preparation of analysis of similar events.
8 Support the preparation of periodic safety reports (eg, DSURs) in accordance with regulatory requirements and standard operating procedures.
9 Provide safety content review of clinical protocols, study reports, Investigators Brochure, informed consents and other related documents, as applicable .
1 Bachelor’s degree in medicine, pharmaceuticals, or biology or Registered Nurse degree
2 3+ years of experience in drug safety/PV in the biotech/pharmaceutical industry
3 Experience with drug safety databases such as Argus is preferred.
4 Vendor management experience preferred.
5 Strong knowledge of pharmacovigilance regulatory requirements (US, EU or China).
6 Strong knowledge of current pharmacovigilance practices.
7 Experience in supporting regulatory authority inspections is preferred.