DEx Lifescience (Pharmacovigilence) M Level

Job Summary - Driving critical audits in Pharmacovigilance and CSV engagement level

audits on a periodic basis identify process non-compliances/ potential delivery failures with

the objective of raising timely alerts/ risks for management intervention/ decision providing

assurance on product/service delivery within the organization norms and guidelines.

Educational Qualification

• Education: Science/Life Science/Pharma/ Biotech Graduate /Post graduate

• Work Experience: Overall experience of 10-12 years in Pharma /Life Sciences industry

Relevant experience of Pharmacovigilance and PV audits 8-10 years

•Good to have experience in Computer System Validations- RAR (Risk Assessment

Reports) IQ (Installation Qualification) OQ (Operation Qualification) PQ (Performance

Qualification) VMP (Validation Management/Master Plan) VMR (Validation

Management/Master Report)

Responsibilities

•Audit Planning Preparation Execution finding classification Reporting Finding

verification and Closure

•Own and conduct various types of internal audits

•Own and support external certifications for ISO audits and client audits

•Assess identify and provide Early Risk Alerts to delivery and leadership teams provide

recommendations to mitigate the same avoiding customer escalations.

•Develop strategic initiatives to maintain and improve the audit function which in turn adds

value to the business.

•Articulate audit reports log the same in the internal tool within the SLA period

•Review the audit findings of other auditors and mentor /upskill them as required

•Verify the CAPA taken by the team objectively and ensure closure of findings within the

SLA and ensure findings don’t become aged and obsolete

•Facilitate the project teams Compliance teams and other teams for the external audits and

customer audits by planning and executing mock assessments.

•Collaborate and work as a team wherever applicable

•Train/Mentor new hires

•Participate in knowledge sharing sessions

•Ensure Audit readiness and execute relevant responsibilities during external

audits/inspections

•Meeting Audit service levels and ensure quality of Audit findings

Essential Skills-

Basic knowledge on Pharma Value Chain Process 21 CFR Part 11 21 CFR Part 820 &

Computer System Validation.

Good knowledge of ICH-GCP Good Pharmacovigilance Practice ISO 9001:2015 ISO

13485 and other applicable governing regulations in Life Science domain.

In-depth understanding of end-to-end clinical trial documentation and compliance

requirements at each stage gates.

Basic Tools knowledge preferable such as Argus ArisG