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PV Spec

Req #: 1700096U_en
Location: , 14 MY
Job Category: Pharmagovigilance
Date Posted: 12/1/2017 4:40:08 AM
Baxter International
Implement and ensure  compliance  to  the  Baxter Pharmacovigilance  (PV) system for  medicinal products  and biologics  in Malaysia/Indonesia, in compliance  with  the  localnational  regulations/ standards; Global PV legislation/ standards; and Baxter policies/  procedures  at a local, regional and global level.
Act as Local Qualified  Person Responsible for  Pharmacovigilance  in Malaysia/Indonesia (as per applicable  local legislation)
Implement risk  management activities  in  Malaysia/Indonesia, as applicable,  and  according  to
Risk Management Plans and assure oversight of medicinal  product  safety
Maintain a thorough understanding of  and comply  with  the  BaxterPharmacovigilance  Quality systems and policies.
Ensure all safety information at a  local level is captured  in the Global Pharmacovigilance  safety database  and  submitted  to   regulatory   authorities  as  per  regulatory   requirements, within reporting timelines.
Ensure  appropriate  liaison  with  country   Medical   Affairs,  Regulatory  Affairs,  Clinical, Quality, Business Units, Legal etc., to ensure Pharmacovigilance input  into country  strategic planning for products  throughout their  lifecycle.
Continually and proactively  improve  and develop  the  PV system and department to  meet  the needs and requirements of Baxter,and Pharmacovigilance regulations  and standards.

Essential Duties and Responsibilities: Local QPPV Role
•               In the capacity of Local QPPV (Local Qualified  Person Responsible for Pharmacovigilance), have an oversight of all pharmacovigilance activities as per applicable local legislation.
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/
•   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
Regulatory Submissions
•         Maintain expert  knowledge of the regulatory reporting requirements and ensure the  reporting rules in the system are aligned to the local reporting requirements.
•    Manage  the  process  for  expedited  submission  of  AEs to  local  authorities with  translation of documents   as  required.  Track  submissions  in  the  Pharmacovigilance   safety  database  and archive all submission records.
•   Respond  to  submission  related  queries  from  the  local  regulatory   authorities and  archive  all regulatory  related correspondence.
Other Responsibilities
•     Ensure a  calendar  of  local  PSUR  (Periodic  Safety Update  Report)  requirements is maintained and  these  local  requirements  are  communicated  to  the  Global  team   and  met.   Perform translations as required.
•    Provide the  appropriate local  inputs  for  the  PSMF (Pharmacovigilance  Systems Master  File)
•    Understand any specific local regulatory  report requirements (e.g., AE line listings request the required   information from   the  Global  team  and  submit   the  reports   to  authorities   as per regulatory  requirements.
•    Provide backup support for other  country  PV activities  when necessary. Other  tasks as assigned  by Regional  APAC Pharmacovigilance

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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