Drug Safety Associate

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

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.

Our Team in Allschwil is looking for a Drug Safety Associate who will be responsible for the case processing of adverse event reports following company standard operating procedures, internal business practices and regulatory guidance documents, to ensure compliance with worldwide safety regulations and corporate policies.

Tasks:

Case processing: completion of full case information on the database, including quality review to ensure accuracy and completeness

• Triage of incoming cases to prioritize for daily workflow management
• Completion of remaining case data entry (including narrative or autonarrative), manual coding, label and approval
• Preparation of SUA summary: Analysis of Similar Events
• Perform quality review of ICSR which includes review of source documents and ensuring that the case is accurate and that corrections to the case, if applicable, are incorporated.
• Liaison with Case Receipt and/or Safety Surveillance Physicians (SSP) staff as appropriate to clarify appropriate information required for case processing
• Other activities relating to case processing as appropriate per case, including but not limited to: o Single case unblinding, Serious Adverse Event (SAE) /Adverse Event (AE) reconciliation, deviation memo preparation, deletion/admin edit requests, review protocol update request forms for accuracy

Processes & procedures: awareness of and input to company procedures and guidance

• Completion of all assigned training on company and GMSO procedural documents relating to case processing
• Completion of training relating to relevant PV Agreements for assigned products
• Participate in designated activities to support revision/creation of case processing procedural documents

Project work: participation in assigned projects, including inspection/audit readiness activities

• Participation in local or global project teams, including on-time delivery of assigned responsibilities 5-10% Global Medical Organization Job Description Drug Safety Associate TV-FRM-06588, Version 10.0 2 of 4
• Participation in inspections and audits as identified, including interviews and provision of requested data

Qualifications

• Registered Nurse or Pharmacist (Certification/licensure is required e.g. RN, RPh, PharmD)
• Health/Biomedical Degree (BS, PhD or other related scientific degree/qualification)
• Bachelors degree, or with knowledge of pharmacovigilance usually exhibited by 2-4 years experience in pharmaceutical safety-related role
• Pharmaceutical industry experience is preferred, with a focus on pharmaceutical safety related areas. Case processing experience is desired
• Knowledge and experience with safety reporting and regulatory compliance, and experience of international safety reporting/regulations are preferred
• Understanding of medical terminology and ability to summarize medical information
• Ability to follow guidelines and procedural documents (experience of working with SOPs etc preferred)
• Ability to prioritize, plan and organize work assignments, and able to work under strict timelines
• Proactive approach/uses own initiative appropriately
• Decision-making and problem-solving skills
• Flexibility and adaptability
• Positive attitude

We are an equal opportunity employer and value diversity at our company. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Have we sparked your interest? Then we expect your full application (CV, Motivational letter) online.

Primary Location
Switzerland-Allschwil– Organization
Actelion Pharmaceuticals Ltd (Swiss Confederation) (8542)
Job Function
R&D
Requisition ID
1905790224W