דרושים Pv Intern ב-Ge Healthcare ב-China, Shanghai

• Intake of emails in shared mailbox and book-in and triage of certain types of safety reports in GAED in accordance with GPV processes and global regulatory requirements and guidelines, ensuring accurate and timely handling.
• Perform data entry and quality review of certain types of safety reports in GAED, including coding of MedDRA terms and preparation of case narratives to ensure the accuracy, consistency and compliance.
• Conduct follow-up activities, including generating and sending out follow-up letters and closing action items in GAED according to company SOPs.
• Interface with internal stakeholders for issues/ requests and escalate as appropriate.
• Ensure archiving of safety data in accordance with regulatory requirement and company SOPs.
• Ensure availability of current organization charts, job descriptions, Curriculum Vitae and training records for safety personnel in the Affiliate(s).
• Conduct Regulatory Intelligence tasks according to instruction.
• Develop knowledge for pharmacovigilance regulations, guidelines and company SOPs and conventions.
• Any other tasks assigned by line manager.

Inclusion and Diversity

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

MAIN RESPONSIBILITIES / DUTIES

1. Perform China Local Pharmacovigilance (PV) daily work, including collection of local spontaneous cases (follow-up activities, if applicable), translation of National Medical Products Administration (NMPA) feedback line listings, translation of China domestic cases in Global database (Argus) and literature monitoring

2. Perform local PV team document (e.g.: PSUR) preparation as per regulatory authorities’ request

4. Perform other MA-PV work (e.g.: management of PV documents such as SIEAs, PV training, support meetings held by MA, and other administrative affairs), if needed

COMPETENCIES REQUIREMENTS

1. Sufficient English and writing skills

2. Familiar with Microsoft Office software (e.g.: Word, Excel and PowerPoint)

3. High sense of responsibility

4. Independent job working capability under coaching

5. Detail-oriented

BACKGROUND REQUIREMENTS

1. Bachelor’s degree or above

2. Major in medicine, pharmacology, medical English, translation and etc.

3. Able to work at least 3 days/wee

Inclusion and Diversity

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.