3 days ago

Senior Drug Safety Physician

Actelion Pharmaceuticals Ltd

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Senior Drug Safety Physician

Senior Drug Safety Physician - (18000009) Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of Johnson &
Johnson, is recruiting for Senior Drug Safety Physician. 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 The resource will work
in a team-oriented global environment and will be responsible for the overall medical evaluation of adverse event
information, conduct routine pharmacovigilance, initiate safety-related product labeling changes based on risk
assessment and prepare safety evaluations for regulatory reports. In particular, the resource will be accountable for
the following activities:

- Management of adverse event information ICSR processing activities
- Maintain active pharmacovigilance for the responsible Actelion's products including accurate signal detection and
risk management
- Safety Management Team activities for the responsible products
- Periodic Safety Reports and other safety-related reports and documents
- Clinical trial, Post-Marketing Surveillance activities (including liaison with Clinical Development and Medical

Additionally, as part of cross-functional activities, the resource will:

- Provide safety expertise and medical consultation in cross functional activities
- Provide support to Medical Information regarding safety questions
- Provide scientific input to Quality Management, when required
- Participate actively or lead project, group and team meetings
- Take charge of specific projects, as appropriate
- Provide medical support to affiliates or contract research organizations
- Create or contribute to standard operating procedures (SOP) and guidelines

Candidate Requirements

- Doctor of Medicine degree with license or equivalent
- International experience in the Drug Safety environment of pharmaceutical industry and in collecting, analysing,
assessing and reporting adverse events associated with investigational and marketed products
- At least three years' experience in multiple areas of Drug Safety management with project lead responsibility
- Knowledge of international safety regulations (primarily EU regulation and ICH)
- Strong verbal and written English communication skills.
- Proficiency with Word, Access, Excel and safety databases
- Excellent organizational, problem-solving, and interpersonal skills and the ability to meet timelines.

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


: Drug Safety


: Full-time

Job Type

: Standard

Job Posting

: Jan 12, 2018