Head of Drug Safety Science, Medical Director

Head of Drug Safety Science, Medical Director

Sobi

Sweden

Position Summary

The Head of Drug Safety Science Group (HDSS) is, in the role as line manager for the Drug Safety Physicians and Drug Safety Managers of the Drug Safety Science Group, actively participates in setting the strategic direction within the Drug Safety department and in decision-making regarding the safety profile of all Sobi MAH products during its life-cycle. The HDSS will provide leadership to the Drug Safety Science Group.and ensures that all safety surveillance and risk management activities are conducted to the highest ethical and scientific standards in compliance with GCP, GVP and other regulatory requirements with the aim of protecting the safety of patients treated with Sobi products and participating in Sobi clinical studies.

Responsibilities

Including, but not limited to the following:

  • In the role as line manager lead, coach and develop a team of Drug Safety Physicians and Drug Safety Managers both from a scientific and operational perspective, with the aim to continuously improve in competence, scientific standards and innovation;
  • Ensure ongoing evaluation of the overall safety profiles for authorized products as well as products under development;
  • Provide medical recommendation on Drug Safety position in benefit-risk matters;
  • Advice Head of Drug Safety and QPPV, and Chief Medical Officer in all patient related matters;
  • Secure the integrity and high standards in the management and delivery of safety medical and scientific expertise in the handling of adverse events and risk management activities during the whole life-cycle of all Sobi products, from early development to mature brands;
  • Secures Drug Safety scientific deliverables to agreed internal and external projects;
  • Proactively plan and balance appropriate resources and deliverables from the group of Drug Safety Physicians and Drug Safety Managers, needed to meet the department and company goals, and its business priorities;
  • Provides strategic, scientific and practical expertise to development, maintenance and oversight of the medical processes throughout key medical Drug Safety processes including preparation of aggregate reports, signal management activities, risk management activites, regulatory submissions and responses to regulatory questions, reference safety information and safety communication;
  • Represent Drug Safety in internal cross-functional collaborations, including interface with Medical Affairs, Translational Medicine and other functions as appropriate;
  • Represent Drug Safety in internal change projects and scientific committees, and mediate and facilitate partnerships and collaborations;
  • Contribute to due diligence activities and negotiations of safety data exchange agreements;
  • Provide input to scientific committee consultations with EMA, FDA and other agencies as appropriate.

Position Qualifications and Experience

Required:

  • Medical Degree, with >5 years clinical experience;
  • More than 10 years from Pharmacovigilance work within the industry;
  • Line management experience;
  • Expert knowledge of regulatory requirements in pharmacovigilance, especially with EU and US.

Desired:

  • Medical Specialization in relevant field (e.g paediatrics, immunology);
  • Degree Pharmaceutical Medicine;
  • PhD or similar academic experience.

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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