Kelly Services

Pharmacovigilance / Medical Advisor Operation Specialist - WFH Special Project

Kelly Services
Salary provided
Posted on 22 Feb 2021

Pharmacovigilance / Medical Advisor Operation Specialist - WFH Special Project

Kelly Services

Job Highlights

  • Pharmacovigilance activities for drug development
  • Process safety data according to SOP
  • 12 months project, Work from home

Job Description

Kelly Services Thailand is currently seeking for “Pharmacovigilance / Medical Advisor Operation Specialistto join an important pharmaceutical project in Thailand.

Responsibilities

  • Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements. 
  • To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming Adverse Events(AE)/endpoint information 
  • determining initial/update status of incoming events 
  • database entry
  • coding AE and Products, writing narratives, Literature related activities, Quality review, assisting with reconciliation, case closure related activities, coordinating translations, as per internal/ project timelines. Creating, maintaining and tracking cases as applicable to the project plan.
  • Perform activities related to adjudication as applicable 
  • Assess Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to meet requirement as per project. Liaise with relevant stakeholders to facilitate expedited reporting.
  • Liaise with manager for regulatory tracking requirements and electronic reporting.
  • Contribute knowledge and expertise to or lead assigned deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.
  • Ensure to meet quality, productivity and delivery standards per project requirements.
  • Ensure compliance to all project related processes and activities.
  • Build a positive, collaborative team environment with Safety team members, lead by example, provide training and mentoring for less experienced team members and operations staff, assist Operations Manager as a backup when needed.
  • Provide and impart technical and process information to Safety Management and members of operational team on project specific issues.
  • Provide oversight role and have a good understanding of operational team on status, metrics, productivity and initiatives.
  • Maintain a thorough understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects set up and maintain project files, standard templates, electronic forms, databases and workflow as per project requirement.
  • Establish and maintain effective team and project service operations communications i.e. provide regular feedback to operations team manager and other relevant stakeholders on project metrics, out of scope work challenges/issues and successes effective feedback on project performance to junior members of team.
  • Read and acknowledge all necessary company standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring completeness of individual training plan and maintain up to date training transcripts.
  • Participate or Lead trainings across Safety process service offerings participate in working groups as applicable in implementation of new initiatives, identification and implementation of process efficiencies.
  • To demonstrate problem solving capabilities.
  • Liaise with different functional team members, e.g. project management, clinical, data management health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues.
  • Attend project team meetings and provide regular feedback/ inputs to Operations team manager on operational project metrics, out of scope work challenges/issues and successes. To liaise with client in relation to details on day to day activities as needed.
  • Contribute to achievement of departmental goals
  • Perform other duties as assigned
  • 100% compliance towards all people practices and processes

Requirements

  • Bachelor's degree in life sciences or related field and up to 5 years of relevant experience, inclusive of up to 3 years of Pharmacovigilance experience.
  • Equivalent combination of education, training and experience
  • Requires intermediate level knowledge of principles, theories, and concepts of a job area, typically obtained through advanced education combined with experience

Term: Contract for 12 months project 

Work location: Work from home (Thailand time)

Laptop and mobile phone will be provided.

Attractive Salary!!

Additional Information

Career Level
Senior
Qualification
Degree
Years of Experience
3 years
Job Type
Contract, Full Time

Company Overview

About PERSOLKELLY

PERSOLKELLY is a joint venture established in 2016 between PERSOL Holdings (previously Temp Holdings) and Kelly Services to cater to the rising workforce employment needs of the emerging Asia Pacific market. We are one of the largest workforce solutions providers in the region, spanning over 50 offices across 13 markets including Australia, China, Hong Kong, India, Indonesia, Malaysia, New Zealand, Philippines, Singapore, South Korea, Taiwan, Thailand and Vietnam.

Our reach, scope, and scale of operations have set the industry standard for cross-border recruitment and holistic workforce solutions. Since inception, PERSOLKELLY has placed over 66,000 positions across the region and works together with 98% of Fortune 100™ companies for their workforce solution needs.

Additional Company Information

Benefits & Others
Five-day work week, Flexible working hours, Medical insurance, Work from home