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PV specialist

Req #: 18000023_en
Location: Kuala Lumpur, 14 MY
Job Category: Patient Safety
Date Posted: 1/7/2018 9:51:53 PM
Baxter International

Description

Safety Risk Management  Activities

 

•    Identify   the local  regulatory   requirements  for  RMP  (Risk Management  Plan)  submissions, communicate the requirements to the Global team and provide local inputs as required. Implementing risk minimization measures locally as appropriate.

•               Perform surveillance   activities   for   any  new  potential  safety  information  (e.g.  similar   AEs reported in a cluster of reports  or multiple cases for one batch received in a short time  frame) and escalate as per procedures

 

PV Quality Systems

 

•    Have a thorough  understanding of  and  comply  with  the  Baxter  Pharmacovigilance   Quality systems and policies.

•    Maintain expert   knowledge and   awareness   of   local   pharmacovigilance  regulations   and implement as appropriate.

•    Ensure adequate understanding of audit and inspection  preparation and readiness.

 

•         Ensure understanding of the CAPA (Corrective  and Preventative  Actions) process. Responsible for performing APA activities as per identified roles.

•    Ensure compliance with procedures  for document management retention and archiving.

 

•    Understand   and  implement  the  document   change  management  process  and  act  as  SME

{Subject Matter Expert) for local procedures

 

•    Ensure all training requirements for the role are met.

 

•   Identify  appropriate stake holders  and ensure they  are trained  on PV reporting requirements/

procedures.

 

•   Build  alignment   and  collaboration  with   local   Regulatory  Affairs,   Medical   Affairs,   Clinical

Operations, Quality Assurance, and Business Unit teams

 

•   Communicate  effectively all relevant  safety information and compliance  concerns with  the  AP Regional PV.

•    Ensure adherence and appropriate implementation BCP {Business  Continuity  Plan).

 

•   With regardsto third  party agreements:

- Ensure the appropriate PV language is incorporated into the agreements.

- Perform  regular  review  of the  agreements  to ensure safety requirements are aligned  to the current  regulatory  requirements and perform  reconciliation of data between  the third  party

and Baxter.

 

 

Case Intake

 

•    Manage  the receipt  and capture  process for adverse event  (AE)and other  safety information report  collection in the Pharmacovigilance safety database.

•   Assess the need for utilizing appropriate forms and questionnaires, complete  appropriate forms and capture the information in the Pharmacovigilance safetydatabase.

•          Perform the initial  assessment on case validity, check for core case elements, perform duplicate checks and request or case deletion  as required.

•   Assess expectedness against the local label.

 

•    Perform  translation of  source  documents  and local  quality  check  of  translation  as required.

Ensure all source documents  are captured in the Pharmacovigilance safety database.

 

•          Determine  the  requirement for  follow  up information and manage the  process for  collection and handling queriesfrom the Globalteam.

•    Perform  ongoing  tracking  and  local  quality  check  of  AE cases for  follow  up and submission requirements.

•    Manage patientidentified batch review requestsas required.

•   Perform reconciliation activities  for AE cases as required

Qualifications

Qualifications. To perform this job successfully, an individual must  be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.

 

 

 

•   Expert knowledge of the PV relevant local regulatory framework, and sound knowledge  of international PV relevant  regulations  and standards,e.g. GVP.

 

•   Excellent analytical & problem solving skills

•   Excellent oral & written communication & interpersonal skills

• Operates effectively  in a team environment

• Ability to work under strict deadlines and changing priorities with some supervision

• Attention to detail

• Strong commitment to compliance  with the relevant  rules and procedures, and to scientific quality and integrity

•  Medical  terminology & clinical knowledge

 

 

 

Education and/or Experience. Include  the education and/or experience that  is necessary to perform the job satisfactorily.

 N/A:   Intern or Co-op

 

 

• Bachelor's degree in a  scientific field preferable in pharmacy

• At least 1-2 year experience in pharmacovigilance

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