Pharmacovigilance Specialist

A leading global pharmaceutical company has a new vacancy for a Pharmacovigilance Specialist to join their expanding Swiss team. The company has a superb pipeline and operates in over 90 countries around the world.

Job Responsibilties:

• PV support for developmental programs, including both early and late stage development as required.
• Supports Vaccines Safety lead for assigned products, e.g. by performing the following activities
• Compilation, analysis and Review of safety data and safety signal management for designated compound(s).
• Prepares/reviews PV section for clinical study protocols, SAPs, clinical study reports, and other documents developed for submission to regulatory authorities
• Prepares/reviews Aggregate Reports: Co-authors Aggregate Reports (PSURs, DSURs) and contributes to the preparation of Ad Hoc Safety Reports (e.g., Health Hazard Evaluations).
• Reviews safety data and participates in dose escalation/continuation of vaccination decisions
• Contributes to Safety Monitoring Plan/Risk Management Plan
• Performs data analysis and drafts regulatory submission documents, for license application and variation activities and for safety issues and questions from regulators
• Contributes to the set-up of safety procedures and development of safety exchange agreements for co-development projects

Skills and Requirements:

• Vaccines and/or biotechnology industry experience preferred
• Minimum 5 years of experience in clinical trials and post marketing pharmacovigilance
• Minimum 3 years of pharmaceutical and/or biotechnology industry experience in Pharmacovigilance functioning as a Pharmacovigilance specialist
• Strong investigational event and aggregate assessment/review/documentation skills.
• Working knowledge of US/EU/APAC regulations and ICH guidelines.
• Experience in communicating with the FDA, EMA, and other global health authorities.
• Sound working knowledge of MedDRA coding.
• Understanding of pharmacovigilance-related information systems.
• Expert in Aggregate Report preparation and review.
• Proven collaborative internal relations with Clinical Development, Regulatory Affairs, Medical Affairs, Quality and Legal Counsel.
• High integrity, sense of urgency, ability to recognize time sensitivity, willingness to be a "player/coach".
• Excellent English written and verbal communication skills, additional languages (e.g., Spanish, Japanese, German) desired.
• Dealing calmly and effectively with high-stress situations. This includes continuing to persevere and remaining calm in challenging circumstances.
• Demonstrated success in building effective matrix working teams, systems, and processes; proven ability to identify, select and manage a variety of external resources.
• Leadership/managerial experience preferred.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Hermann Baer on + 41 78 679 7787 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.