Drug Safety Specialist (Grade Sr Manager) ** Major PharmaCo ** Expanding Teams *

Reference: MG10479B1

Expiry Date: 04-10-2019

Categories Biotech, Clinical Research

Salary: On Application

Job Type: Full Time

Location:
Düsseldorf
Germany

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Job Description

Drug Safety Specialist (Grade Sr Manager) ** Major PharmaCo ** Expanding Teams *

Location: North Rhine-Westphalia

This is a role working with a leading bio-pharmaceutical company based in North Rhine-Westphalia and would appeal to individuals working in Drug Safety who want to climb up the ladder and gain wider geographical responsibility.

Pharmacovigilance System

  • Maintain a functional connection with the EEA Qualified Person for Pharmacovigilance (QPPV) e.g. participating in regular Local Safety Officer (LSO) meetings organized by corporate Patient Safety;
  • Ensure that the required local information for the Pharmacovigilance System Master File (PSMF) is made available to the EEA QPPV office, either directly or through local delegations;
  • Implement and maintain a pharmacovigilance system for the company products authorized in the territory and ensure compliance with applicable regulatory and company requirements;
  • Work in close collaboration with corporate safety teams to ensure that local obligations are managed and compliance to local authorities is maintained.

In collaboration with the Regional Safety Leader and the Graduated Plan Officer for Germany:

Pharmacovigilance System

  • Maintain a functional connection with the EEA Qualified Person for Pharmacovigilance (QPPV) e.g. participating in regular Local Safety Officer (LSO) meetings organized by corporate Safety;
  • Ensure that the required local information for the Pharmacovigilance System Master File (PSMF) is made available to the EEA QPPV office, either directly or through local delegations;
  • Implement and maintain a pharmacovigilance system for the company products authorized in the territory and ensure compliance with applicable regulatory and company requirements;
  • Work in close collaboration with corporate Patient Safety teams to ensure that local obligations are managed and compliance to local authorities is maintained;
  • Provide input into global/local processes to secure compliance.

Patient Support Programs/Market Research programs/Digital initiatives

  • Collaborate in true partnership with business units in programs leading to solutions for patients plus ensure compliant set up and oversight;
  • Proactive assessment of the capability and capacity of PSP/MRP vendors to conduct critical pharmacovigilance tasks (in support of qualification audits) and avoid issues of regulatory compliance.

Safety communication

  • Knowledge of product safety risks to act proactively and independently with local stakeholders (e.g. DHCP letter) and proactively escalate local safety issues to the Safety Leads as appropriate;
  • Champion the coordination and enable effective safety communication to HAs/HCPs and patients and ensure appropriate follow-up.

Health Authority inspections and Audit readiness

  • Ensure inspection and audit readiness of the relevant local departments in full collaboration with corporate Patient Safety and Quality Assurance;
  • Participate in and manage pharmacovigilance audits and inspections, perform root cause analysis, ensuring timely identification and implementation of respective Corrective Actions Preventive Actions (CAPAs).

Staff Qualification and Training

  • Ensure that staff managing safety activities for or on behalf of the affiliate have the appropriate qualification and training.

For the job you will need a Bachelor’s Degree or a Master’s Degree. You will also need HCP based education (such as physician, pharmacist, nurse) or any relevant graduation / experience in medical-scientific area (such as PhD/master in biological sciences or related degree). The job requires minimum 2 to 5 years in Pharmacovigilance.

 

To Apply!

To apply and learn more about his role, please follow the link on this webpage. You can also contact me, Martin on + 44 (0)20 7801 3382 for an initial discussion about the role and other projects.

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