Sr. Medical Safety & PV Compliance Specialist

     

JOB DESCRIPTION:

Primary Job Function:

As an individual contributor, assists in managing the receipt, processing, and maintenance of safety related information as it relates to Abbott Nutrition products in compliance with applicable regulatory requirements and guidelines. Assists in ensuring that the pharmacovigilance system in place for Abbott Nutrition products registered as drugs is in place and is in compliance with corporate and regulatory standards.

Core Job Responsibilities:

• Adverse Event Management: receipting, processing, exchanging and submission of Individual case safety reports (ICSRs) in clinical trail and post-marketing for Abbott Nutrition products in a compliant and timely manner to meet applicable regulatory requirementsand global requirement.
• Vendor managment: Manage/commuinicate with vendors to make sure they are compliant with the corresponding PV agreements/SOPs/WIs/regulations.
• Safety Training: Assists in ensuring all Affiliate employees and contractors in Affiliate are aware of their responsibility to complete annual adverse event identification and reporting training. Ensures training of Affiliate personnel on relevant pharmacovigilance responsibilities is undertaken at least annually and that appropriate training records are maintained and appropriately documented.
• Aggregate Safety Report support: Support to coordinate review and submission of PSURs/PBRERs, PV Annual Reports, Drug Annual reports, and other locally required Aggregate Safety Reports.
• Audits and Inspections: Support both internal pharmacovigilance audits and Regulatory Authority pharmacovigilance inspections.
• Assists QPPV in maintenance and oversight of the pharmacovigilance system for Abbott Nutrition products registered as drugs.
• Works with QPPV to ensure local processes and procedures are in place that are aligned with global SOPs and local regulations.
• Supporting pharmacovigilance activities in other countries in the Pacific Asia region.

Position Accountability/Scope:

Financial impact is at the department level and directly results from either non-compliance with regulations or delayed response time. Able to prioritize workload independently. Does not initiate strategic decisions but is responsible for supporting the department, division, and company’s strategic direction. Workload responsibilities are task-related and include higher level functioning (ex: prioritizing workload, training, independently compiling data for reports, ensuring compliance with regulations).  May have additional interdepartmental exposure based on specific project involvement or training responsibilities.  Work has a major impact on the organization’s regulatory compliance. 

Minimum Education:

Bachelor’s degree in related life sciences, medical, pharmacy, or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job.

Minimum Experience/Training Required:

• Better to have Previous experience working with pharmaceutical industry, 1-3 year pharmacovigilance experience.
• understanding of domestic, reginal and global regulations related to nutritional products and drugs.
• Understanding of department SOPs, and clinical knowledge to apply to adverse event data collection and processing. 
• Fluency in written English, Japanese is essential in order to accurate translation and presentation of safety profile/data.
• Computer proficient (Windows, Word, Excel) and proficient in working in adverse event databases.
• Good communication and interpersonal skills, both written and spoken.
• Good organizational skills with proven ability to prioritize and work on multiple tasks and projects.
• Strong commitment to compliance with the relevant rules and procedures and to scientific quality and integrity.

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Medical & Scientific Affairs

     

DIVISION:

ANRD Nutrition Research & Development

        

LOCATION:

China > Shanghai : 1036 Tianlin Road, Caohejing Business Park SBP Phase III

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable