Senior Pharmacovigilance QA Manager

Job content

About Idorsia Pharmaceuticals Ltd

Idorsia Ltd is reaching out for more - We have more ideas, we see more opportunities and we want to help more patients.

In order to achieve this, we want to develop Idorsia into one of Europe’s leading biopharmaceutical companies, with a strong scientific core.

Headquartered in Switzerland - a European biotech hub - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet – the ideal constellation to bringing R&D efforts to business success.

Idorsia was listed on the SIX Swiss Exchange (ticker symbol: IDIA) in June 2017 and has over 1,100 highly qualified specialists dedicated to realizing our ambitious targets.

We are looking for a Senior Pharmacovigilance QA Manager to join the team !

Job’s Responsibilities

This role within the Pharmacovigilance (PV) QA team at Idorsia is key to deliver high quality audits across the globe covering all aspects of a fully functional PV system in Idorsia including our interactions with other pharmaceutical companies, service providers and distributors.

• Execute a risk-based, global PV QA audit program covering internal (PV system, affiliates) and external (service provider, licensing/marketing partner, distributor) audits to verify adherence to the PV system: Independently leads the planning, conduct and reporting of routine and non-routine Pharmacovigilance audits of activities, data, internal facilities and processes to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements. Non-routine audits include Due Diligence, for cause audits, complex/sensitive system/service provider audits as defined by the scope.
• Ensures the relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.
• Ensure that corrective/preventive actions have been identified, documented and are effective. Provides expert support to auditees when developing CAPAs. Influence consistency of CAPAs for similar issues.
• Contribute to official escalation of significant PV compliance issues
• Provides expertise and knowledge to less experienced auditors, internal stakeholders (Global Drug Safety, Global regulatory affairs, Marketing, Medical Affairs, Medical Information, affiliates,...) on quality and compliance processes/procedures. Interprets and applies regulations/ policies to complex issues in order to influence decisions and actions, when required. Communicates internally to ensure a departmental unified position regarding advice and consultation is provided.
• Takes an active role in projects as assigned by supervisor and interacts with key stakeholders as appropriate.
• Meets priorities, checkpoints and timelines for all aspects of work and projects to achieve adequate progress
• Participates in regulatory (affiliate and HQ) PV inspections in core and supporting roles during preparation, conduct, reporting and follow up phases
• Ensures personal compliance with training at all times and contribute/build training materials as needed, for training and/or coaching PV QA staff. Train and coach other PV QA staff.
• Maintain expert level of knowledge of current global pharmacovigilance regulations, updates to regulations and good pharmacovigilance practices.
• Maintain oversight and review the content of key global and local QS Documents relating to the PV system.
• Use best (industry) practice to implement and support continuous QA process excellence and improvement activities
• May serve as deputy for PV QA Lead when requested and may supervise junior auditors and contractors, if required.
  

Candidate’s Requirements

• Education: Graduate Degree in Pharmacy, or other scientific and health related fields; strong background in Quality Assurance/Compliance
• Demonstrated audit/inspection experience as PV auditor/inspector
• Expert level of International (primarily, EU, US regulations & ICH guidelines) Pharmacovigilance Regulation knowledge with the ability to provide critical information, advice and guidance on complex quality and compliance issues.
• In-depth knowledge of pharmaceutical industry practices
• Approximately 7-10 years of experience in the pharmaceutical industry/health authority within PV.
• Excellent communication (verbal and written), interpersonal skills
• Investigation, problem solving, risk analysis & management, negotiation and influencing skills
• Ability to work independently as well as in a team environment
• Experienced in the training of employees on GVP requirements and pharmaceutical industry practices
• Prior experience hosting/supporting Pharmacovigilance inspections performed by Competent Regulatory Authorities, e.g. FDA, EMA, MHRA, ANSM, BfArM
• Reliable, conscientious, goal oriented
• Excellent at problem solving applying diplomatic skills while solving difficult situation and ability to measure and manage risk(s) associated with PV activities
• Ability to communicate effectively with all levels of the organization
• Experience in international cross-cultural relations
• Ability to travel at least 20% of the time
• Proficient in the use of Microsoft Office applications
• Languages: fluent in English - knowledge of second language would be advantageous
  

What Idorsia Offers

• Exciting opportunities for development and professional growth within our dynamic organization
• A collaborative and solution-oriented environment where you can make a difference
• An innovative and open culture in a truly multicultural environment
• A competitive salary and generous benefits
  

Work Location: Allschwil - Basel Area

Country: Switzerland (CH)

Business Area: Quality Assurance

Schedule: Full time

Job Type: Permanent

Job ID: 3619

At Idorsia, we harness the power of difference, authenticity, and inclusion to achieve business success.

We encourage all potential candidates with diverse backgrounds of race, color, religion, sexual orientation, gender identity, age, national origin, and disability to submit their job applications. All applicants will receive consideration.

We are committed to fostering respect, fairness, and equal opportunities for all job applicants and our employees.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.

Please note Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates, or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.