Director, Deputy Qualified Person for Pharmacovigilance
MSD Switzerland
Czech Republic
před 2 dny

Description

For our Global Clinical Safety & Pharmacovigilance department we are currently recruiting a :

Director, Deputy Qualified Person for Pharmacovigilance

Based in Brussels or another EU-country (except United Kingdom)

The position

Reporting into the Associate Vice President / European Qualified Person Risk Management & Pharmacovigilance (QPPV) you will represent MSD as a Deputy to the EU Qualified Person for Pharmacovigilance.

This position is required under current European Union (EU) Regulations, Directives and Guidance. You will, in back-up to the EU QPPV, carry responsibility for ensuring compliance with all EU regulatory requirements relating to PV for products approved in the EU.

You will have broad oversight of all aspects of the global PV system which are applicable in the EU and as such you will interact closely with the EU QPPV, Regulatory Affairs Europe, European Economic Area (EEA) subsidiary employees and EU regulatory authorities concerning all aspects of PV.

You will interact closely with Global Pharmacovigilance and Quality Assurance and you will have a particular focus on the EEA Regional PV Head and country-

based PV staff to ensure oversight of the PV system at a country level in the EU. Finally you will interact with all relevant corporate functions and internal groups that impact PV.

Main areas of responsibility :

  • With and in back-up to QPPV, acting as a pivotal liaison point between the EMA and the Company regarding safety data submissions.
  • Establishing and maintaining good relations and effective communications with the EMA and Member State Authorities to ensure timely communication to the company of any potential safety issue and for clarification of requirements relating to PV.

  • Providing EU QPPV back-up for oversight of issues related to the safety profiles for all MSD medicinal products with an approved market authorization in the EU.
  • Including input into aggregate reports, Risk Management Planning, Crisis Management and review of EU PASS;
  • Supports the EU QPPV as back-up on relevant Management and Oversight Committees and Teams;
  • Having oversight of the establishment and maintenance of a pharmacovigilance system and thereafter full access to content.
  • Maintaining Policies, Standard Operating Procedures and Execution Resources specific to the Office of the EU QPPV, plus ensuring accurate maintenance of the MSD Pharmacovigilance System Master File and related documents;
  • Having oversight to ensure compliance with expedited and aggregate submission requirements to all EU Member State Agencies and / or the EMA as required by EU Regulations and Directives, including review of and input to standard operating procedures, key performance indicators, and corrective and preventative actions;
  • Supporting EU QPPV involvement in and authority over the establishment and maintenance of the global PV system through oversight of database development and related procedures, plus input into quality control and quality assurance processes and procedures;
  • Leading or supporting assessment of EU PV requirements changes for any impact on Company policies / procedures and resources of contact.
  • Maintaining awareness of any findings and resulting actions, providing QPPV input as appropriate;
  • Interacting with and engaging EU regulatory agency representatives and industry thought leaders to provide industry expert input into new regulations and guidance concerning regulatory requirements and drug safety.
  • Representing MSD in relevant national and international expert groups, key to PV.

    Qualifications

  • Academic degree in health care specialty (required), MD (Medical Doctor) degree is a strong plus;
  • At least 15 years of experience in the pharmaceutical area with experience in health sciences, regulatory affairs or post-
  • marketing safety surveillance of which at least five years of experience in the area of clinical safety and pharmacovigilance;
  • Demonstrated knowledge of EU requirements concerning pharmacovigilance;
  • Good knowledge of the pharmaceutical development process and of the EU environment;
  • Working knowledge of appropriate terminology, computer systems and data management;
  • Demonstrated ability to work effectively across functions and divisions and ability to influence at a senior management level;
  • Strong organizational and planning skills;
  • Lives and operates in the EU (Ex UK) and willing to travel incidentally (maximum 10% of time);
  • Excellent written and oral communication skills in English.
  • Information

    Questions and further information regarding the position can be addressed to Guy Demol, Associate Vice President / European Qualified Person Risk Management & Pharmacovigilance (QPPV), based in Brussels, by phone : 00 32 2 7767014.

    Application

    If you are interested in this challenging role, you are invited to apply online by uploading your resume and application letter.

    About MSD

    MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.

    Today, we are building a new kind of healthcare company one that is ready to help create a healthier future for all of us.

    Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.

    To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

    Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.

    Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.

    Search Firm Representatives Please Read Carefully :

    MSD is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails.

    All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and / or method without a valid written search agreement in place for this position will be deemed the sole property of MSD.

    No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.

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