Director Pvqa, Apac

**Director PharmacoVigilance Quality Assurance (PVQA) - APAC**

Location : Singapore

Department : R&D PV QA

Reporting to : Head of Global PVQA

Territory : Asia Pacific

Travel % : up to 30%

**ABOUT THE BUSINESS**

Our client is a global pharmaceu8cal company with more than 100 years of scientific expertise and specializes in developing oncology and cardiovascular drugs providing innovative products and services around the world.

**QUALIFICATIONS**

**Education**
- Bachelor's Degree in Life Sciences, Pharmacy or Medicines required
- Master’s Degree, preferred
- PhD or advanced degree in Life Sciences, Pharmacy or Medicines preferred

**Work Experience**
- 10 or more years of involvement in regulated activities, PharmacoVigilance, QA (preferably) and clinical development leadership positions; broad understanding of global expectations of Health Authorities in the area of Clinical Development; profound understanding of the science of product development preferred.
- Demonstrated experience and broad understanding of Pharmacovigilance, post marketing studies and post approval safety studies (PASS).
- 10 or more years of demonstrated accomplishments in a global/matrix environment in the pharmaceutical industry.
- Must have expertise in leading/managing (Global) projects and Clinical Safety or Pharmacovigilance activities
- Must possess strong leadership, interpersonal, communication, negotiation and problem-solving skills.
- Must have ability to work independently and in a team environment.
- Demonstrated experience and proven track record of successfully leading projects with high impact.
- Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors. Preferred
- Considerable organization awareness (e.g., interrelationship of departments, business priorities), including significant experience working cross
- functionally and in global teams.
- Strong industry network in clinical development. Knowledge and understanding of cultural differences and diversity issues.
- Strong written and oral communication skills (English).

**Competencies**
- Profound knowledge of global drug development
- Demonstrated experience of successfully supporting projects of high impact
- Demonstrated agility in a global/matrix environment
- Strong interpersonal skills with demonstrated ability to build collaborative relationships
- Strong project management skills
- Thorough and extensive knowledge of ICH-GCP including FDA/EU regulations, pharmacovigilance, new drug regulations, other key HA guidance’s and current industry practice
- Excellent verbal and written communication skills and computer skills.
- Excellent problem solving and decision-making skills. Skilled at conflict resolution/negotiation
- Capable of working independently as well as part of a cross functional team demonstrating the ability to influence and create alignment across multiple functional areas
- Flexibility to react to changing priorities in a dynamic business environment
- Considerable organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams across different regions of the world

**RESPONSIBILITIES**

**Customer Focus / Regulatory Inspections (30%)**
- Provide quality oversight for Oncology and Specialty Medicine portfolios, aligning with the business strategy.
- Support the implementation of the quality strategy, tracking progress on Quality Manual breakdown into an actionable annual Quality Plan, monitor progress of the Quality plan including risk assessments and inspection readiness activities. Ensure proactive representation of Quality professionals at strategic non-project team and at CSPV strategic discussions as assigned.
- Lead inspection management activities by ensuring continued submission, compliance and inspection preparedness for the respective PV inspections in alignment with regulatory and company strategy specifically within the APAC region
- Act as PV QA management representative for key health authority inspections in the APAC region (China FDI, Taiwan FDA, etc). Develop and maintain an effective working relationship with

US FDA and other international bodies such as China-NMPA, Taiwan FDA etc.
- Lead and/or manage license partner audits, and represent PV QA at relevant strategic discussions and ensure safety risks are identified and mitigated
- Ensure timely and effective implementation of Corrective and Preventive Actions (CAPAs) during inspections, license partner audits.
- Ensure adequate CAPAs are defined, implemented and closed by providing guidance and facilitation of quality event resolution.
- Proactively ensure that all functions consistently operate in a state of compliance.
- May be tasked as a QA reviewer to support/ lead the review of the safety section of the dossier for regulatory submissions in collaboration with the Audit and Compliance team.
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