Head of Pharmacovigilance and Medical Information

Head of Pharmacovigilance and Medical Information

AbbVie

Vienna, Austria

Job Description:

  • Leadership and management of the local Pharmacovigilance Team;
  • Ensuring that Quality System/Standard Operating Procedures are in place;
  • Adverse Event Reporting;
  • Organized Data Collection Programs (Patient Support, Market Research and Social Media Programs);
  • Ensuring training compliance with Global and Local PV training requirements in all needed systems;
  • Acting as the key Affiliate contact for both internal PV audits and Regulatory Authority PV inspections;
  • Risk Management;
  • Safety Monitoring;
  • Ensuring Affiliate Medical Information activities are able to comply 100% with SAE/SAR reporting timelines as outlined in the companys equalty standard by accurate & timely cooperation with the Affiliate Safety Representative;
  • Ensuring that all local regulations for Medical Information are met within your area of responsibility, support the Affiliate Medical Departement in the management of copyright rules.

Qualifications:

  • Medical, pharmacy or life-sciences degree (or equivalent);
  • Fluency in written and oral local language (German) a requirement in order to facilitate communications within the affiliate medical department, and with the National Regulatory Authority;
  • Minimum of 5 years' experience working in the pharmaceutical industry in a drug safety role is strongly preferred for the Affiliate Safety Representative role;
  • Successful track record of leading a team;
  • Excellent written and spoken communication and presentation skills;
  • Effective decision maker who possesses the ability to assess impact of actions taken locally on the global PV system;
  • Fluency in written and oral English is essential in order to facilitate communications with Pharmacovigilance and Patient Safety, Regional Medical and other headquarters functions;
  • High customer orientation;
  • Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity;
  • Sound judgment, strong planning and organizational skills, and the ability to get things done. Demonstrated strong sense of urgency;
  • Strong influencing skills with the ability to explain and defend a position which is in the best interests of patient safety;
  • Keen interest in maintaining expert knowledge for assigned therapeutic areas/products and in medical research in general;
  • High degree of commitment and diligence;
  • Collaborative, team-oriented approach, able to develop and support relationships across an organization;
  • Works independently: limited guidance/oversight. Works broadly across functions to facilitate and support the affiliate's medical and clinical activities as necessary;
  • Strategic and analytic working habit.

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© EuroJobsites 2019

EuroJobsites is a 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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