PV Associate- Compliance is responsible for raising process deviations, review,
documentation, monitoring and follow up of process deviations and implementation of CAPA,
Audit and Inspection readiness.
Responsibilities:
. Act as SME for deviation and CAPA handling activities during audit and regulatory
authority inspections, as needed.
. Collate all CAPA from internal QA audit and Health Authority Inspection and maintain in
a summary spreadsheet.
. Review the deviations and CAPA for completeness.
. Follow up on open deviations/CAPA with CAPA owners to ensure completion within
agreed timelines. This monitoring will require contact with CAPA owners prior to the
due date to ensure CAPAs remain on track.
. Liaise with country affiliates as necessary to receive updates on progress of CAPA for
local process deviations and as a result of internal audit/external inspection
. Work closely with the PV Quality & Compliance Lead to ensure oversight of deviations
and CAPAs and that summary data is available for presentation at the monthly
compliance meeting.
. Ensure deviation and CAPA data is available in a format which can be easily included in
the PSMF.
. Ensure that information concerning closed deviations/CAPA are appropriately archived.
. Filing and Archiving: Maintain PV shared folders for safety information, and maintain
document security and integrity by filing documents securely on site or sending files to
archive.
. Provide data for internal compliance meetings, monthly report and for inclusion in the
PSMF as required
. Support for PV QMS: Support the development and revision of department SOPs and
work instructions. Also participate in the review of cross-functional SOPs which include
reference to PV activities.
. Support during Audit & Inspection by collating and providing PV relevant data.
. Perform other ad hoc, PV related activities as requested by management.
Relationship Management
. Working within PV team and cross-functionally.
. Interactions with vendor's/service providers for PV activities.
Process Improvement / Standardization
. Participate in streamlining Global integration project under supervision of Global Head
of PV.
Desired Skills & Competencies
. Valuable working knowledge of PV regulations including FDA, EU & local requirements.
. Performs timely coordination of safety information dissemination with minimal direct
supervision.
. Excellent teamwork and interpersonal skills.
. Excellent time management and organisational skills.
. Good knowledge of computer applications and software, including MS Word, Excel,
PowerPoint etc.
M. Pharm or equivalent with 2 to 4 years of experience in pharmacovigilance