GE HealthCare Associate PV Manager 

Kenya, Nairobi County, Nairobi 

991429329

The job holder functions as Deputy of Pharmacovigilance (PV) Responsible Person and medical device event (MDE) monitoring Responsible Person in China Local Safety Unit (LSU) and assist to establish, operate, and continuously improve PV/MDE system in China that meets regulatory requirements and company SOPs and ensure compliance of event monitoring and reporting and to supervise the identification, assessment, and control of drug/medical device safety risks to ensure the effective implementation of risk control measures in China. This position may also include activities supporting global PV initiatives within Global Medical Services (GMS) and other tasks upon request.

Essential Responsibilities

• Detect, collect, record, translate, book in AEs or other safety information from all sources(for drug and medical device)and notify Central Safety Unit (CSU) in a timely and complete manner.
• Perform monthly reconciliation with GMS Compliance Team to ensure compliance to regulatory regulations and GEHC policy.
• Perform medical or scientific literature in local language are reviewed to identify possible adverse events or special situations reportable to CSU in timely manner.
• Support the review, localization, and submission of aggregate reports to ensure compliant to relevant regulatory requirements.
• Filing safety related information and other LSU documents (e.g. CV, JD, training log, org-chart etc.) according to local regulatory requirement and company SOPs
• Support the preparation and renewal ofsafety agreements (SIEA/SDEA)and ensure local safety reports are forwarded to partners according to the agreements.
• Provide PV/MDEtrainings to local staff, new hiring, distributors, or 3rd party contractors to enhance awareness of their reporting responsibility.
• Support the management of local PV/MDESOPs/ Work Instructions and China PSMF with high quality.
• Assist in audits and inspections.
• Maintain effective connection with internal and external stake holders to collect insight and promote PV value.
• Support the regulatory affairs (RA) department, quality assurance (QA) department and other relevant functional departments on PV/MDErelated content or safety related enquiries.
• Provide prompt response to local health authorities (HA) for PV/MDErelated request or queries, and support projects or activities of engaging local HA.
• Monitoring local PV/MDEregulatory requirement updates and support the conduct of gap analysis.
• Support safety management from clinical trials include but not limited to review contracts, protocols and Investigator Brochures, Safety Management Plan, DSURs and other PV related documents upon request.
• Attend high value PV/MDErelated conference or training program.
• Covers for the PV/MDEResponsible Person during absence or leaves.
• Any other tasks assigned by PV/MDEResponsible Person (this could include collaboration, communication and cross functional working opportunities within GPV team).

Qualifications/Requirements

• Bachelor’s degree or above, major in medical, pharmaceutical, epidemiological, or related.
• At least 3 years of pharmaceutical/biotechnology industry experience in pharmacovigilance.
• Up-to-date knowledge of current China regulations and industry guidelines governing pharmacovigilance.
• Competent oral and written English.
• Excellent interpersonal, oral, and written communication skills to a range of internal and external customers
• Skilled in Microsoft Office applications (Word, PowerPoint, Excel).

Desired Characteristics

• Highly organized, analytical, and logical in approach to all assigned tasks.
• Ability to manage multiple priorities.
• High integrity, sense of urgency, ability to recognize time sensitivity.
• Strong problem solving and negotiation skills.
• Being open to change (positive or negative) in response to new information, different or unexpected circumstances.
• User experience with Safety database (e.g. Argus)