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.

Qualifications

M. Pharm or equivalent with 2 to 4 years of experience in pharmacovigilance
- Job Family: Medical Affairs & Pharmacovigilance
- Sub Job Family: Pharmacovigilance
- Preferred type of working: On-Premise
- Business unit: GMO

📌 PV Associate-Compliance (Hyderabad)
🏢 Dr. Reddy's Laboratories
📍 Hyderabad