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Senior Specialist, Regulatory & PV Network

🕒 10 days ago
PharmacovigilanceRegulatory StrategyProject ManagementICH GCP

📜 Description

  • Act as Local Contact Person for Pharmacovigilance for the designated country
  • With the help of a senior member of the team, develop strategy and manage set up activities (Project Management Plan, joint operating procedures, POAs and core documents)
  • Provide strategic input to internal and external customers and promptly identify and address any risk/potential risk by implementing preventive measures
  • Problem solve and support achievement of satisfactory resolution of performance issues or delivery failures
  • Collect, review, track and maintain LCPs' CVs, job descriptions, training records, contact details and monthly reports
  • Ensure correct training assignment to and training compliance by the LCPs
  • Ensure all team members assigned to the project for departmental deliverables are aware of the tasks and time allocated, monitor project budgets, hours spent vs budgeted and promptly identify and escalate any OoS
  • Prepare client’s invoices and review/approve vendors’ project invoices
  • Provide training, coaching and mentoring to junior members of staff

🛠️ Requirements

  • Bachelor's Degree in Chemistry or Life Sciences, Nursing, or equivalent experience
  • Strong experience within pharmaceutical or CRO industry or Regulatory body
  • Good knowledge of ICH GCP and/or GVP and national regulations for territories of competency
  • PV training and/or working experience and other educational or professional background as required locally
  • Fluent in English, both written and verbal
  • Candidate must be proficient in the official language of the country in which they are based, as this is essential for local interactions and compliance
  • Good planning and organizational skills
  • Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
  • Good attention to detail
  • Provide support to proposal development and input to budgets, provide department representation to BD meetings as required

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