
Pharmacovigilance Area Head, Apac
1 week ago
**OBJECTIVE**:
- Responsible for overseeing the quality management and compliance activities as they relate to Post-Market Safety of the applicable affiliate office(s) in the APAC Area.
- Supports and provides audit/inspection readiness and pharmacovigilance oversight, functional expertise and leadership to the Cluster and/or Country Leads within the assigned area.
- Works in partnership with GPSE to ensure systems and processes are in place to best support and ensure regulatory compliance for PV locally, regionally and globally where Takeda holds MAH / markets products.
- Works in partnership with other local, regional and global stakeholders (R&D and APAC BU) to ensure oversight and support of the PV system.
- Acts as point of contact for any safety related issues and escalation in the one of the Clusters or Country in the APAC Area.
**ACCOUNTABILITIES**:
- Accountable and responsible for aligning and co-coordinating PV activities across the clusters and LOCs in APAC Area.
- Develops the pharmacovigilance capabilities across the APAC Area.
- Manage cluster / LOC PV resources, including PV vendors, and works with direct reports on ensuring appropriate capability development requirements are defined and actioned including goal setting, performance management, team guidance and training.
- Ensures PV compliance with required PV regulations across APAC Area.
- Works with PV Cluster/ LOC Leads to set the goals, priorities, key performance metrics and long-term plans within the respective Cluster/ LOC in the APAC Area:
- Appropriate resourcing / outsourcing strategies.
- Meets regulatory requirements and compliance.
- Sets training priorities.
- Guides and provides support to the Cluster / LOC for implementation of specific Pharmacovigilance strategy (aligned with Global and / or regional where applicable).
- Identifies synergies and best practice sharing across LOCs.
- Ensure PV systems and procedures are appropriately implemented / functioning across the LOCs within the APAC Area:
- Responsible for oversight and support in implementation of local SOPs where needed.
- Oversee Global SOP Implementation at LOC level.
- Oversee adherence Compliance to Local PV Regulations and applicable regional, and global requirements.
- Responsible for issues escalation within and external to PVAR Head for GEM (RICA) as required.
- Responsible to cascade relevant PV information (e.g. global, regional and area) to key stakeholders (e.g. Medical Affairs, Regulatory Affairs, Quality Assurance and Compliance) for full alignment in support of corporate goals and in support of business needs.
- Establish and maintain strong relationships with key stakeholders to promote PV and Patient Safety.
- Provide leadership to PV Cluster and Country Leads and /or Patient Safety Leads.
- Facilitate and contributes to the development of career path opportunities for local PSLs within their cluster / country.
- Support the PVAR Patients Access Lead in APAC Area Access Markets in to ensure Patient Safety in donations programs and PAP and work with the Patient Access Lead to establish PV communication platform where needed.
**QUALIFICATIONS**
Education and Experience
- Bachelor’s required. Health professional (nursing etc) or life science degree and/or advanced degree preferred.
- Extensive pharmaceutical or healthcare-related industry experience required.
- Advanced experience in PV-related environments, preferably at local, regional and/or global levels.
- Advanced experience of working cross-functionally.
- Understanding of medical/scientific terminology.
- Excellent knowledge of PV regulations for the post-marketing global environment and regional legislation in particular.
- Experience of a mixed resource model and/or vendor management preferred;
- Experience of line management preferred
Skills and Competencies
- Excellent written/oral communication skills and experience working within virtual teams.
- Accuracy and attention to detail.
- Flexible mindset.
- High degree of cross-cultural awareness.
- Team worker with collaborative approach.
- Ability to prioritize under pressure.
- Well-developed organizational skills.
- High standard of computer literacy.
**Locations**:
Singapore, Singapore
**Worker Type**:
Employee
**Worker Sub-Type**:
Regular
**Time Type**:
Full time
-
Singapore INTEGRITY PARTNERS PTE. LTD. Full timeOur client is a Pharmaceutical MNC with an established team of self-driven internationals. As part of their on-going endeavour to recruit dynamic talent, they are now seeking a Pharmacovigilance Executive to support their growth within the APAC region. **Responsibilities** - Risk management plans - Provision of safety information - Implementation of PV...
-
APAC Compliance Specialist
2 days ago
Singapore beBeeRegulatory Full time $90,000 - $120,000Key ResponsibilitiesThe primary role of the Regulatory Manager will be to act as a liaison between Head Quarters and all Partners on Regulatory matters for Asia Pacific countries.Coordinate and manage queries, variations, submissions and registrations.Handle product issues or complaints as well as quality concerns.Maintain PDM (Product Data Management)...
-
Director Pvqa, Apac
2 weeks ago
Singapore INTEGRITY PARTNERS PTE. LTD. Full time**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...
-
Aspac Regional Head, Local Safety
1 week ago
Singapore Johnson & Johnson Full timeJohnson & Johnson is currently recruiting for an ASPAC Regional Head, Local Safety (New Consumer Health Company). This position is located in Singapore. Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing innovative ideas, products and services to...
-
Singapore Johnson & Johnson Full timeJohnson & Johnson is currently recruiting for a PV Auditor - Lead Specialist APAC (New Consumer Health Company). This position will be located in Shanghai, China or Singapore. Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science bringing innovative ideas,...
-
Head of Lending Apac
1 week ago
Singapore ING Full timeAs the head of Lending APAC, you are a dynamic and multifaceted senior leader who will lead the regional business through a pivotal phase of growth and transformation. Anchored in the Wholesale Banking Lending strategy, you are responsible for overseeing and managing a diversified lending portfolio, ensuring a balanced mix of loan products and client...
-
Head of Workplace Management, Apac
2 weeks ago
Singapore JLL Full timeAbout JLL - We’re JLL—a leading professional services and investment management firm specializing in real estate. We have operations in over 80 countries and a workforce of over 91,000 individuals around the world who help real estate owners, occupiers and investors achieve their business ambitions. As a global Fortune 500 company, we also have an...
-
Area Safety Team Lead, South East Asia
1 day ago
Singapore Johnson & Johnson Full timeThe Area Safety Team Lead, South East Asia (SEA), is the safety leader for Pharma and Consumer products for the South East Asia region, including Malaysia & Brunei, Indonesia, Philippines, Singapore, Thailand & LCM, and Vietnam. The Area Safety Team Lead, SEA will report to the Asia Pacific Cross-Sector Safety Head, International Pharmacovigilance. He/she...
-
Head of HR APAC
1 week ago
Singapore Frazer Jones Full timeHead of HR APAC - Global Financial ServicesFrazer Jones is retained by a leading international financial services group to appoint a Head of HR APAC (Senior Director) based in Singapore.This strategic leadership role involves overseeing a high-performing, collaborative, and geographically dispersed team of Country HR Heads and Regional HR Business Partner...
-
Head of Retail,
7 days ago
Singapore Flying Tiger Copenhagen Full time**Join Our APAC Regional Team as Head of Retail, Asia Pacific (APAC)!** **Are you a dynamic retail leader ready to take on a pivotal role across a diverse and fast-growing region?**We’re looking for a Head of Retail, Asia Pacific to lead sales growth and drive operational excellence within one of the world’s most fun and innovative retail brands.** As...