PV Associate-Compliance

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
Good 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