Recruiting.com

Regulatory Affairs, Pharmacovigilance/Quality Management Control Manager

Recruiting.com

full-time

Posted on:

Location Type: Remote

Location: Thailand

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About the role

  • Accountability for the execution of operational tasks in the Regulatory Strategy & Procedure Management Practice Area that requires established experience and specific scientific expertise in the sector of human and veterinary medicinal products.
  • Develop and maintain strong client relationships and actively explore opportunities for increased service support to Line Manager.
  • Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products.
  • Preparation, review and compilation of documents within the framework of regulatory affairs projects.
  • Communication with clients and Health Authorities.
  • Support with scientific advice procedures and representation of clients with health authorities.
  • Responsible for the planning and execution of client projects in accordance with Key Performance Indicators.
  • Coordination of project teams with colleagues and qualified external partners.
  • General guidance (consultancy) of colleagues and clients regarding Regulatory Strategy and Procedure Management.
  • Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues.
  • Present seminars and lectures for colleagues, clients and professional audiences.
  • Active contribution and distribution of department relevant expertise.
  • Support with Value Delivery Centre strategy implementation and optimization.
  • Comply with, maintain and contribute to optimizing internal processes.
  • Support with Value Delivery Centre led commercial, marketing and business development activities including proposal input.
  • Support respective lead in delivery to budget with accurate and timely reporting and provide project insights to address invoicing queries.
  • Providing on-site regulatory support to Global Consulting Services clients.
  • Set up and manage the local pharmacovigilance system, including oversight of local Pharmacovigilance activities.
  • Local Literature Search.
  • Local Individual Case Safety Report Collection and Management.
  • Pharmacovigilance Intelligence Screening.
  • Local Pharmacovigilance System Master File Maintenance.
  • Setting up Local Organized Data Collection.
  • Local Pharmacovigilance Agreement Management.
  • Local adaptation and submission of Periodic Safety Update Reports/Risk Management Plan.
  • Local signal detection.
  • Implementation of additional Risk Minimization Measures.
  • Reviewing materials relating to local post-authorization safety studies.
  • Participate in Pharmacovigilance-relevant audits and inspections.
  • Attend regular meetings according to project meeting schedule.
  • Provide monthly Pharmacovigilance report on status of local Pharmacovigilance system in the country/ies.
  • Ensure Pharmacovigilance training of affiliate employees, service providers and Third Parties.

Requirements

  • Proven experience, or demonstrable capability, in area of responsibility or similar field
  • University degree in Life Science
  • Ability to implement tactical goals of customer or internal projects within daily work
  • Ability to prioritize parallel tasks, identify potential road blocks and initiate appropriate counter measures
  • Structured, analytical, systematic and independent way of working; some discretion to take action consistent with operating policies, determines own priorities
  • Ability to analyze and solve problems and to develop pragmatic solutions for a given task or project
  • High service orientation
  • Ability to train and support junior/new colleagues in daily activities; ability to lead small project with clearly defined scope
  • Ability to manage internal and external (client) relationships on operational/day-to-day working level as well as client's team lead level
  • Good communication skills (written and verbally);
  • Good presentation skills and confident appearance.
Benefits
  • Benefit offerings outside the US may vary by country and will be aligned to local market practice.
  • The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
regulatory affairspharmacovigilancerisk managementmedical device regulationmarketing authorizationsafety report managementdata collectionsignal detectionliterature searchproject management
Soft skills
client relationship managementproblem solvinganalytical skillscommunication skillspresentation skillsservice orientationteam leadershiporganizational skillsindependent workingtactical goal implementation
Certifications
university degree in Life Science