3 days ago

Pharmacovigilance Quality Assurance Manager

Actelion Pharmaceuticals Ltd

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Pharmacovigilance Quality Assurance Manager

Pharmacovigilance Quality Assurance Manager - (1700009D)

Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for
Pharmacovigilance Quality Assurance Manager .

As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without
disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us.
We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of
everyone in it.

Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our portfolio of PAH treatments covers the
spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.

Job Responsibilities

- Plan, conduct and follow up on:

- operational PV audits at Actelion affiliates
- third party operational PV audits and pre-contract assessments
- global PV relevant process/system audits

- Participate in contractual partner PV audits
- Contribute to PV system audits conducted by the Computerized System Validation (CSV) QA group
- Track completion of agreed upon CAPAs as a result of regulatory authority inspections and contractual partner PV
- Act as global quality contact to affiliates worldwide and maintain close working relationship with local Quality
Champions, providing support, training and consultancy on local Quality Systems and GxP topics
- Develop and maintain procedural documents for Post Marketing Quality Assurance (PMQA) and the affiliates, and
participate in the development of corporate PV SOPs as appropriate
- Maintain the quality section of the Pharmacovigilance System Master File (PSMF)
- Contribute to organization and content preparation for the annual Global quality event (Quality Summit)
- Lead and/or participate in QA system projects for the PMQA group

Candidate Requirements

- University degree in a Business related or Scientific field
- At least 3 years of operational experience in Drug Safety
- At least 1 year in Quality Assurance as an Auditor
- In-depth knowledge of international Pharmacovigilance regulations and guidance documents and understanding of their
practical implications
- Excellent interpersonal and communication skills
- Fluency in written and spoken English
- Capable to work independently and as part of a team
- Strong analytical skills
- Ability to prioritize tasks
- Strong decision-making skills
- Ability to travel 20% of the time

If you are interested in making an impact by working in a culture of innovation, trust and teamwork, we welcome your

Primary Location

: CH-BL-Allschwil


: Quality


: Full-time

Job Type

: Standard

Job Posting

: Dec 11, 2017