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Pharmacovigilance/Safety Vigilance Manager (Taguig City)

Job Category:

Others

Job Level:

Managerial

Open Date:

24-Feb-2021

Location:

TAGUIG CITY

Close date:

30-Apr-2021

Client Overview:

Our client is one of the medical pharmaceutical company from Japan. They are listed one of the largest pharmaceutical company in Japan and they have 3,805 employees all around the world. Their main products are eye drops for hospital and consumer use. 

They started here in the Philippines in 2015 as the trading and distributor of the eye drops in different pharmacies and hospitals in the Philippines.

Client Industry:

TRADING

Job Description and Qualification:

Job Description:
  • Lead the planning, preparation of strategy, maintenance and execution of safety vigilance (SV) activities to realize high quality and consistency of the products, medical devices, supplements etc.) in the Philippines at both the development and commercial stages. 
  • Ensures communication to Head of Asia Safety Vigilance Operation of any relevant change in relation to the product portfolio, licensing activities, clinical trial and post-marketing activities, local processes, local SV regulation, audits and inspections activities, and health authorities’ requests.
  • Responsible for ensuring that all regional safety vigilance operation for client Medicines and Medical devices is appropriate in terms of structure and performance, to comply with global standards, policies and procedures related to Safety vigilance
Main Responsibilities:
  • Develops and maintains strong internal cross functional and an external network to facilitate the smooth Safety Vigilance operations in the Philippines.
  • Represent Philippines Safety Vigilance to proactively provide SV input/support to business projects/initiatives. 
  • Conducts safety data collection from any source and all kinds of safety reporting to concerned stakeholders is performed in compliance with internal procedures and according to current local and international legal requirements. 
  • Maintains an appropriate single case management system, including: receipt of domestic cases and distribution to global data entry, responses to queries including tracking, reporting of received cases according to local legal requirements. 
  • Screens all local Safety Vigilance literatures 
  • Arranges and reviews SV related agreements in Philippines. 
  • Conducts post marketing surveillance activities including relevant vendor management and investigator management. 
  • Provides adequate safety vigilance trainings to relevant internal/external stakeholders at country level. 
  • Establishes and supports local inspection readiness, participate in SV audits and SV inspections as required. 
  • Coordinates and monitors risk minimization measures as necessary for all products in Philippines. 
  • Monitors local SV activities and regularly reports status to global headquarters. 
  • Maintains awareness of local Safety Vigilance regulations and updates local Vigilance activities and processes as necessary to maintain compliance with local regulations 
  • Plans local SV budget, provide necessary inputs in forecasting and maintain adequate handling of SV budget. 
  • Provides support to SV related activities/projects according to the direction made by head of SVAO at any given time. 
Qualifications:
  • A Bachelor's Degree Graduate preferably BS Pharmacy graduate
  • With or Without Pharmacist License
  • With at least 10 years of related work experience,
  • With at least 3-5 years managerial experience
  • With Regulatory Affairs background 
  • Excellent knowledge of regulation relating to Pharmacovigilance 
  • Relevant experience on Pharmacovigilance including post marketing surveillance activities. 
  • Familiarity with and ability to work as a stand-alone Pharmacovigilance unit within a global Safety Vigilance Structure 
  • Preferably worked in a multinational company in the related industry
  • Ability to effectively participate in multi-disciplinary teams; strong hands-on leadership and management skills 
  • Solid decision making skills, inter-dependent partnering skills, team-orientation and demonstrated ability to influence outcomes.
  • Solid computer skills, using MS Office / Word.
  • Well-organized and detail oriented, with strong verbal and written communication skills in English 
  • Knowledge of products development process, eye diseases, and ophthalmic products.
  • Willing to work ASAP
Perks:
  • Work-from-Home set-up (whether in the absence and presence of COVID-19 vacine)
  • Competitive salary offer with guaranteed transportation allowance (even working from home)
  • HMO (employee only)
  • With annual performance based bonus
  • Work tools: Postpaid phones and Laptop 
  • Regular work schedule: Monday to Friday (8:30am-5:30pm)