Head of Pharmacovilgilance, Medical Quality

vor 5 Monaten

Wiesbaden, Deutschland AbbVie Vollzeit

**Unternehmensbeschreibung**
**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 and Medical Information**

**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.
- 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 overvi

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