PV Associate-Compliance

PV Associate-Compliance

Job Description

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.

Qualifications

M. Pharm or equivalent with 2 to 4 years of experience in pharmacovigilance

Experience Level

Mid Level