Pharmacovigilance Affairs Specialist

Industry Category	Healthcare	Position	Pharmacy
Recruitment Department		Number Of Recruits	several
Work Location	All Cities	Nature Of Work	Full Time
Gender Requirements	Male	Marriage Requirement	No marital status restrictions
Education Level	College Diploma	Work Experience	No work experience restrictions
Age Requirement	Above 18 years old	Salary Package	Negotiable
Updated Date	2022-10-25	Valid Until	Valid for a long time

The IPV Affairs Specialist will support the Global IPV Affairs Team in all IPV operations and compliance tasks related to the vigilance of the product portfolio under the umbrella of International Pharmacovigilance (IPV). The IPV Affairs Specialist will work in close partnership with Regional Heads, Local Safety Teams and Case Management Team to ensure adequate centralization of activities enabling process optimization and increasing efficiencies. The IPV Affairs Specialist will ensure a consistent operations approach across the regions in alignment with the Global Medical Safety (GMS) and Global Medical Organization (GMO) processes for areas of responsibility. The IPV Affairs Specialist in partnership with IPV Affairs Project Lead will lead or participate in global or regional multi-disciplinary projects and shape strategies for the projects assigned. The IPV Affairs specialist may be involved in IPV process including: 

General

Serve as a Member of the Global IPV Affairs TeamBe an ambassador of the Office of the Chief Medical Officer (OCMO) culture and visionFor areas under responsibility act as Subject Matter Expert for the IPV organization, drive and/or support on finding most suitable and efficient solutions during discussions with different cross functional teams and collaborate on reviewing and streamlining applicable procedural documents.Support IPV organization on applicable operational tasks and ensure overall inspection readiness across IPV.Work in close partnership with IPV Affairs members across regions to ensure a global consistent approach for IPV

IPV Project Management

Lead and/or participate as specialized function in regional or global projects for areas of expertise to streamline and optimize PV operations.

Compliance oversight & Metrics for IPV

Contribute to the development of an integrated and standardized IPV quality systemDevelop a globally consistent approach for assessing, recording and reporting of countries compliance status in close cooperation with CSA international. Escalate alert signals of non-compliance.Support preparing the compliance oversight reports and meetings needed for the different stakeholders for final review by the IPV Leadership teamFocus on risk identification and support mitigation as needed.Initiate, lead, and support continuous improvement initiatives based on quality and compliance of Key Performance Indicators (KPIs) and Key Risk Indicators (KRIs).

Qualifications:

•              Medical, pharmaceutical or nature science degree with proven expertise and experience in pharmaceutical industry and experience in Pharmacovigilance

•              Minimum of 3 years’ experience in a position within Pharmacovigilance

•              Proven management capability with the ability to simplify complex workflows and simultaneously manage critical issues in a complex and changing internal and external environment.

•              Task-oriented with proven experience in the delivery of high-quality work and able to operate autonomously without direct supervision and as part of a multi-disciplinary team In-depth understanding of vigilance systems and processes; knowledge of or experience with International Pharmacovigilance and compliance regulations and guidelines is an advantage for this role.

•              Demonstrable insight to the development of regulatory requirements with knowledge of Global aspects of drug/devices safety, including international reporting requirements and relevant country-specific variations within the region.

•              Proven Project Management experience including stakeholder management and change management

•              Knowledge and experience in data management/visualization platforms a big plus (Tableau etc)

•              Experience in

•              Excellent computer-based application skills

•              Fluent communication skills in English, any additional language is a plus

Desirable profiles and experience include:

•              Experienced CAPA coaches

•              Pharmacovigilance Regulations Handling experience

•              Pharmacovigilance Compliance Metrics Management and Handling

•              Technical knowledge and experience on data management and visualization platform (Tableau etc)

 Educational Attainment:

Medical, pharmaceutical or nature science degree with proven expertise and experience in pharmaceutical industry and experience in Pharmacovigilance. Bachelor’s degree or Master’s degree (preferred) in technical, scientific, or engineering disciplines required. Biomedical Engineer, Registered Pharmacist, Registered Nurse, Physician Assistant or similar healthcare provider/science license/certification/degree preferred.

Working set up: Hybrid set up

ManpowerGroup is the world leader in employment services for almost 70 years. Every day, we connect people to meaningful work. Whether you are just a fresh graduate trying to enter the workforce or a professional looking for a career change, we are here to help you navigate the world of work and make the experience better for you.About ManpowerGroupManpowerGroup (NYSE: MAN) has been the world’s workforce expert, creating innovative workforce solutions, for nearly 70 years. We connect more than 600,000 men and women to meaningful work across a wide range of skills and industries every day. Through our ManpowerGroup family of brands — Manpower, Experis, Right Management and ManpowerGroup Solutions — we help more than 400,000 clients in 80 countries and territories address their critical talent needs, providing comprehensive solutions to resource, manage and develop talent. ManpowerGroup operates in the Philippines through its wholly owned subsidiary Manpower Outsourcing Services Inc. (MOSI) and its local affiliate, Prime Manpower Resources Development, Inc. (Prime Manpower).About MOSIManpower Outsourcing Services Inc. (MOSI) is a wholly owned subsidiary of ManpowerGroup. We provide a continuum of staffing solutions to enhance business agility and competitiveness in an ever-changing world of work. At any given time, MOSI deploys 1800+ associates to its ever growing list of multinational clients.