hero

Find Your Dream Job Today

Our mission is to help high-achieving LGBTQ+ undergraduates reach their full potential.

Head of Pharmacovigilance/ Medical Quality / Medical Information (all genders)

AbbVie

AbbVie

Quality Assurance
Wiesbaden, Germany
Posted on Tuesday, June 11, 2024

Unternehmensbeschreibung

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Stellenbeschreibung

People. Passion. Possibilities. It’s who we are, what we do, and what we stand for.

In our Pharmacovigilance department within Commercial Pharma at the Wiesbaden site, you will be working in a team of talented people and experienced management experts. Through valuable analyses and research efforts, you will be laying down benchmarks and shaping the future of our brand.

Together, we break through – as Head of Pharmacovigilance/ Medical Quality / Medical Information (all genders)

Primary function:

  • Lead the coordination and execution of all aspects of Pharmacovigilance (PV), Medical Quality (MedQ) and Medical Information (MI) at the affiliate to ensure that AbbVie’s statutory and ethical responsibilities are met.
  • Act as the Affiliate’s main contact point for PV matters with the National Competent Authority (-iea) and AbbVie Pharmacovigilance and Patient Safety function (PPS).
  • Serve as the Graduated Plan Officer PV (Stufenplanbeauftragter PV) as per Arzneimittelgesetz (AMG; German Drug Law) and Arzneimittel- und Wirkstoffherstellungs-verordnung (AMWHV; German Ordinance on the Production of Pharmaceuticals and Active Substances), with sufficient authority to influence the performance of the quality system and pharmacovigilance activities and to promote, maintain and improve compliance with the legal requirements including all aspects detailed in § 63a AMG and § 19 AMWHV.
  • Provide strategic leadership to manage and support the PV, MedQ and MI team in executing assigned responsibilities.

Leadership and management:

  • Build and maintain effective business relationships across the affiliate to support the implementation of patient safety standards.
  • Maintain an environment of continuous improvement to optimize the affiliate PV/MedQ/MI system and contribute to regional and global process improvement initiatives, working with PPS subject matter experts.
  • Support recruitment, on-boarding, training, development through coaching and mentoring, performance management, and succession planning of appropriately skilled PV/MedQ/MI staff.

Oversight of the Pharmacovigilance System:

  • Maintain oversight of affiliate PV compliance status, including the compliance status of outsourcing vendor, and actively monitor PV workload and resources.
  • Escalate compliance issues and potential PV resources issues in a timely to ensure appropriate mitigation.
  • Maintain awareness and monitor local post-marketing and clinical PV legislation, to ensure PV legislation changes are communicated to relevant stakeholders for review, impact assessment, implementation and mitigation according to global procedures.

Quality Management System:

  • Ensure the Affiliate PV System procedure(s) aligns with corporate PV procedures and complies with local and regional PV regulations. Ensure local processes and procedures are in place to clearly define MedQ and MI processes.
  • Ensure that any non-conformity and/or planned departures from procedures are managed according to the global issue and exception management process and ensure any corrective/preventive actions are completed according to the schedule.
  • Oversee the training plan and ensure training compliance of local PV personnel and other affiliate personnel.
  • Oversee training compliance of partner company staff according to local contract requirements.

Adverse Event & Periodic Safety Reporting:

  • Ensure that processes, procedures and systems are in place for intake, processing, conducting follow up and translating and reconciling adverse events and other safety information reportable to PPS from spontaneous and solicited sources and from clinical studies.
  • Ensure reporting of both clinical and post-marketing Individual Case Safety Reports (ICSRs) and Periodic and Aggregate Reports to the Competent Authority, Ethics Committees and Investigators, to comply with corporate PV procedures and with local and regional PV regulations as required.

Partnership with business partner with possibility for identification and/or handling of safety information:

  • Partner with Program Owners and commercial leaders to ensure that all business partnerships involving activities where there is a reasonable possibility for the identification and/or handling of safety information are assessed for the generation of safety information and the applicable PV requirements are applied in accordance with AbbVie procedures and local requirements.

Safety Data Exchange Agreements (SDEA) and other PV Agreements:

  • Ensure the content of local SDEAs and other PV agreements conforms to AbbVie procedures and local requirements.
  • Maintain and monitor compliance with local agreements.

Audits and Inspections:

  • Acts as the key Affiliate contact for both internal PV audits and Regulatory Authority PV inspections.
  • Ensure that any audit/inspection responses/corrective actions are completed according to the schedule.

Risk Management:

  • As a member of the Affiliate Risk Management Team (ARMT), review all Risk Management Plans (RMPs) and implement risk minimization measures at the affiliate

Safety Monitoring:

  • Maintain overview of medicinal product safety profiles and any emerging safety concerns for company products, and awareness of conditions or obligations adopted as part of the marketing authorizations, commitments relating to safety or the safe use of the products and of post-authorization safety studies requested by a regulatory authority.
  • Understand and monitor incoming local safety data and communicate changes or potential concerns to the global Product Safety Team Lead and the EU QPPV (for products marketed in the EEA) for evaluation.
  • Ensure a full and prompt response to regulatory authority requests for provision of additional information necessary for the benefit-risk evaluation of a medicinal product.

After Hours Availability & Business Continuity:

  • Ensure availability to be at AbbVie’s disposal permanently and continuously on a 24-hour basis as the Stufenplanbeauftragte PV.
  • Ensure that an after-hours process is in place for collection and reporting of adverse events.
  • Ensure that a Disaster Recovery Plan/Business Continuity Plan is established in a risk-based manner to allow for continuation of critical business processes for PV and MI.

Qualifikationen

  • Medical, pharmacy or life-sciences degree (or equivalent)
  • At least five years’ experience working in the pharmaceutical industry in a PV role is required.
  • Successful track record of leading a team
  • Adequate theoretical knowledge and practical experience of PV, MI and Quality activities and system under purview (as stipulated in local guidance) and sound understanding of the regulatory and PV monitoring requirements for Germany that comply with any specific training requirements mandated by relevant Competent Authority. Required expert knowledge and the reliability necessary for exercising the function of the Stufenplanbeauftragter PV
  • Excellent written and spoken communication and presentation skills
  • Fluency in written and oral English is essential to facilitate communications with Area/ headquarters functions
  • Fluency in written and oral German to facilitate communications with e.g. the National Competent Authority(-ies)
  • 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

Zusätzliche Informationen

Here's how we can move mountains together:

● with a diverse work environment where you can have a real impact

● with an open corporate culture

● with an attractive salary

● with an intensive onboarding process with a mentor at your side

● with flexible work models for a healthy work-life balance

● with a corporate health management that offers comprehensive health and exercise programs

● with company social benefits

● with a wide range of career opportunities in an international organization

● with top-tier, attractive development opportunities

● with a strong international network

Multiple times, we have been globally recognized as a "Great Place to Work" and we are proud to provide our employees with the flexibility to maintain a healthy work-life balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality, equity, diversity and inclusion (EED&I) – a commitment that is fundamental to us. This includes appreciating different perspectives, creating an inclusive culture and treating all employees with dignity and respect.

At AbbVie, your individual contributions count – help us move mountains together. Be a part of our success, grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you? We look forward to receiving your application! All you need is a complete CV – we will discuss everything else with you in person.

Any questions? Feel free to email as at [email protected] – we look forward to hearing from you!

Nur gemeinsam können wir das Beste für Patienten erreichen. Daher setzen wir bei AbbVie auf Chancengleichheit, Vielfalt & Inklusion. Wir gestalten ein Arbeitsumfeld, in dem alle Mitarbeiter ihr Potenzial entfalten können – unabhängig von Geschlecht, Herkunft, Religion, sexueller Orientierung oder anderen Vielfaltsdimensionen. Doch für uns bedeutet Vielfalt mehr als nur offensichtliche Unterschiede zu berücksichtigen: Sie bezieht sich auch auf unterschiedliche Ausbildungshintergründe, Fachkenntnisse, Persönlichkeitstypen, Denkweisen und Lebenserfahrungen.