Location : Switzerland (flexible) 

Who is Aixial Group ?

Aixial Group, CRO (Clinical Research Organization), specialized in Life Science. We work with laboratories to provide technical support on clinical projects from phases I to IV and post market.

Since 2014, we have been part of the Alten family.

We are developing our activities in Switzerland, France, Belgium, Czech Republic, Denmark, UK, US…with even more prospects for expanding internationally.

Aixial Group, operates in outsouring, insourcing, for pharmaceutical, cosmetic, medical device, biotechnology, nutrition,… activities in clinical operations, regulatory affairs, quality, biometrics, pharmacovigilance, HEOR…

Aixial Group continues to grow, and to recruit in the clinical trial professions. Come and join us, and discover our site to follow the news of our offers.

The Team of Aixial Group Switzerland is looking for his next Senior Scientist Pharmacovigilance (M/F) !

ROLE SUMMARY :

The Senior Scientist Pharmacovigilance (M/F) serves as a product lead or provides support for Pharmacovigilance activities within Safety. The Senior Scientist Pharmacovigilance (M/F) is responsible for overseeing or supporting the process for safety signal management activities, aggregate reports (PSURs, DSURs, Line Listings, RMPs), responding to safety questions from internal and external stakeholders, reviewing medical and scientific literature for safety information, and supporting Clinical Trial PV medical activities.

The PV Scientist also serves as a Subject Matter Expert for Safety and cross-functional teams on relevant global safety regulations and guidelines; data output and analyses; and product specific information. In this capacity, the PV Scientist is critical to ensure products in clinical trials continue to maintain good standing with countries where studies are ongoing to ensure clinical studies are completed, and for marketed products, ensures the marketing authorization remains in good standing.

KEY RESPONSIBILITIES :

• Leads or supports the signal management process (i.e., signal detection, signal tracking, signal documentation, facilitating decisions regarding signals and safety risk, etc.) for assigned product(s) and evaluates safety data and signals as part of ongoing pharmacovigilance activities. Includes synthesis of data from multiple sources and authoring signal evaluation reports. Leads signaling review process and product Safety Signaling Team meetings. Manages literature review for safety information.

• Leads or supports process for responding to safety questions from regulatory authorities.

• Leads or supports Aggregate Report management, including strategy, review and finalization of aggregate safety reports for assigned products, such as PSURs, DSURs, Pharmacovigilance Plans, Risk Evaluation and Mitigation Strategy Plans (REMS), and Risk Management Plans (RMPs).

• Collaborates with Global Safety Officers and other Safety MDs for assigned investigational programs including clinical trial activities (protocol review, ICF review, etc.), safety committee management, data analysis, signal detection, ad hoc requests and other product activities, as assigned.

YOUR PROFILE :

• Bachelor’s Degree in biologic or natural science; or health case discipline; or Advanced degree (PhD, MPH, NP, PharmD, etc.) required

• Minimum 4-7 years Pharmacovigilance experience, including experience in aggregate safety reports and safety signal management.

• Understands, interprets, analyzes, and clearly presents scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology).

• Leads and conducts, independently and/or collaboratively, all aspects of substantive projects such as signaling, authoring of aggregate data reports, and responses to regulatory agency requests

• Strong Pharmacovigilance and drug development foundation, including knowledge of applicable clinical trial safety regulations and post-marketing safety regulations. Includes knowledge of case processing, expedited reporting rules, and safety database concepts.

• Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects). Knowledge of common safety database systems.

• Demonstrates leadership and interacts collaboratively and effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as with external colleagues

• Applies clinical judgment to interpret case information.

• Strong organizational skills, including the ability to prioritize independently with minimal supervision

Why Join Us?

• Make a positive impact and be at the forefront of project: You will be part of ground breaking advancement in clinical research that has positive impacts on millions of people’s lives globally.

• Career Development: People are our biggest asset. We are committed to empower our team continually and build a positive and supportive environment that fosters growth, flexibility, and teamwork. At Aixial Group, you will be coached and mentored throughout your journey to help you advance your professional and personal growth.

• Our commitment to Diversity, Equality, and Inclusion: We aim to create a workforce which promotes dignity and respect, where individual differences are recognized and valued, and where each employee can give their best. Gender equality is at the core of the development strategy of Aixial Group.

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