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03.03.2021

Head of Signal Management - Geneva or Zurich

  • Switzerland - Glattbrugg/Zurich
  • Vollzeitstelle

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Die Vifor Pharma Gruppe – die frühere Galenica Gruppe – ist ein globales Spezialitäten-Pharmaunternehmen, das eigene Pharmaprodukte erforscht, entwickelt, herstellt und vertreibt und ein bevorzugter Partner für innovative patientenorientierte Lösungen ist.
Das Unternehmen hat sich zum Ziel gesetzt, ein globaler Marktführer in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu sein und weltweit Patienten mit schweren und chronischen Erkrankungen zu einem besseren Leben in Gesundheit zu verhelfen.
Die Vifor Pharma Gruppe verfügt über Produktionsstätten in der Schweiz und in Portugal sowie über ein dynamisches Netzwerk von Vertriebsgesellschaften und Partnern zur weltweiten Marktabdeckung. Das Unternehmen treibt die Expansion seiner weltweiten Präsenz laufend voran, bleibt dabei aber in seinem schweizerischen Heimmarkt fest verwurzelt.
Die Vifor Pharma Gruppe besteht aus Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma, ihrem gemeinsamen Unternehmen mit Fresenius Medical Care, Relypsa und OM Pharma.
Die Vifor Pharma Gruppe – die frühere Galenica Gruppe – ist ein globales Spezialitäten-Pharmaunternehmen, das eigene Pharmaprodukte erforscht, entwickelt, herstellt und vertreibt und ein bevorzugter Partner für innovative patientenorientierte Lösungen ist.
Das Unternehmen hat sich zum Ziel gesetzt, ein globaler Marktführer in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu sein und weltweit Patienten mit schweren und chronischen Erkrankungen zu einem besseren Leben in Gesundheit zu verhelfen.
Die Vifor Pharma Gruppe verfügt über Produktionsstätten in der Schweiz und in Portugal sowie über ein dynamisches Netzwerk von Vertriebsgesellschaften und Partnern zur weltweiten Marktabdeckung. Das Unternehmen treibt die Expansion seiner weltweiten Präsenz laufend voran, bleibt dabei aber in seinem schweizerischen Heimmarkt fest verwurzelt.
Die Vifor Pharma Gruppe besteht aus Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma, ihrem gemeinsamen Unternehmen mit Fresenius Medical Care, Relypsa und OM Pharma.

Head of Signal Management - Geneva or Zurich

Location: Switzerland - Glattbrugg/Zurich
Function: Drug Safety/Pharmacovigilance
Company: Vifor Pharma
Medha Khanna
Senior Talent Acquisition Manager

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Agency policy
About you

Are you an experienced pharmacovigilance professional looking for a new challenge?

Vifor Pharma has an opportunity for a Head of Signal Management to join their drug safety function. This role can be based in Geneva or Glattbrugg.

Responsibilities

  • Ensuring ICH/FDA/ and EMA Guidelines compliance

  • Responsible of the whole process of signal detection and management

  • Responsible, in close collaboration with Drug Safety Lead and Therapy Area Lead, that all tasks relating to Signal detection and management are properly conducted in time

  • Responsible, in close collaboration with Case Management, that data sources for signal detection are available and robust

  • Responsible, in close collaboration with any Service Provider that all subcontracted tasks related to Signal management are properly conducted in due time

  • Acting as key contact point for Signal detection and management

  • Acting as owner of all procedural documents and ensuring regular review and updates

  • Participating to Audits/Inspection as company specialist of Signal detection and management

  • Collaborating with Drug Safety Leads/Therapeutic Area Leads for the implementation and improvement of the process

  • Collaborating with Head Clinical Drug Safety for Signal management in clinical safety data sets

  • Collaborating with Medical Writing Unit for aggregate safety reports writing

  • Medical evaluation of adverse event reports

  • Acting as QPPV for Switzerland as per Drug Authorization Ordinance and Ordinance on Medicinal Products

Requirements

  • PhD/ Equivalent with experience in International Drug Safety, ideally operational as well as clinical drug safety

  • Experience in data analysis, signal detection and benefit/risk evaluation

  • Excellent knowledge of international regulations (ICH, Volume 9A/10, EMA GvP ,FDA regulations and Swiss regulations)

  • Fluency in English

  • Knowledge and experience in Pharmacoepidemiology

  • Demonstrated ability to set up and implement drug safety strategies, risk management plans, develop Drug Safety systems and procedures, and elevate and resolve issues.

  • Demonstrated proficiency in problem-solving with respect to pharmaceutical Drug Safety issues.

  • Good computer literacy with experience with safety data bases (ARIS G preferably)

 
About us

Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The company’s goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives.

Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world.

The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.

Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.

For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are

Apply
Agency policy

Head of Signal Management - Geneva or Zurich

Are you an experienced pharmacovigilance professional looking for a new challenge?

Vifor Pharma has an opportunity for a Head of Signal Management to join their drug safety function. This role can be based in Geneva or Glattbrugg.

Responsibilities

  • Ensuring ICH/FDA/ and EMA Guidelines compliance

  • Responsible of the whole process of signal detection and management

  • Responsible, in close collaboration with Drug Safety Lead and Therapy Area Lead, that all tasks relating to Signal detection and management are properly conducted in time

  • Responsible, in close collaboration with Case Management, that data sources for signal detection are available and robust

  • Responsible, in close collaboration with any Service Provider that all subcontracted tasks related to Signal management are properly conducted in due time

  • Acting as key contact point for Signal detection and management

  • Acting as owner of all procedural documents and ensuring regular review and updates

  • Participating to Audits/Inspection as company specialist of Signal detection and management

  • Collaborating with Drug Safety Leads/Therapeutic Area Leads for the implementation and improvement of the process

  • Collaborating with Head Clinical Drug Safety for Signal management in clinical safety data sets

  • Collaborating with Medical Writing Unit for aggregate safety reports writing

  • Medical evaluation of adverse event reports

  • Acting as QPPV for Switzerland as per Drug Authorization Ordinance and Ordinance on Medicinal Products

Requirements

  • PhD/ Equivalent with experience in International Drug Safety, ideally operational as well as clinical drug safety

  • Experience in data analysis, signal detection and benefit/risk evaluation

  • Excellent knowledge of international regulations (ICH, Volume 9A/10, EMA GvP ,FDA regulations and Swiss regulations)

  • Fluency in English

  • Knowledge and experience in Pharmacoepidemiology

  • Demonstrated ability to set up and implement drug safety strategies, risk management plans, develop Drug Safety systems and procedures, and elevate and resolve issues.

  • Demonstrated proficiency in problem-solving with respect to pharmaceutical Drug Safety issues.

  • Good computer literacy with experience with safety data bases (ARIS G preferably)

Vifor Pharma
Drug Safety/Pharmacovigilance

Arbeitsort:

Switzerland - Glattbrugg/Zurich

Medha Khanna
Senior Talent Acquisition Manager