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Boston Office: 99 Hayden Ave, Lexington, MA 02421, US

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Copyright: JACOBIO PHARMACEUTICALS GROUP CO., LTD.   Beijing ICP B 17065868-1   

 

 

Post name:

PV Manager

Salary:
Based upon experience
Work location:
Boston USA
Department:
Clinical Department
Position:
1
Job nature:
Full time
Work related experience:
No limit
Education:
Regular college
Post date:
2021/07/29
Page view :
Post description:

Responsibilities:

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 .

Requirements:

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.