Pharmacovigilance (PV) Scientist

Biogen

Baar, Switzerland

About This Role:

As a Pharmacovigilance (PV) Scientist, you will embark on a pivotal role within our dynamic safety and pharmacovigilance team. Your primary focus will be managing and executing safety-related tasks for designated products or product groups. Your contribution will be multifaceted, including performing vital signal management, crafting meticulous safety evaluations, and overseeing aggregate report authoring. You will provide ad hoc regulatory responses, conduct thorough safety literature reviews, and actively participate in clinical trial safety teams. You will provide expertise on global safety regulations and guidelines, analysing data outputs and product information. Your work will directly impact the well-being of patients and the success of our product portfolio, seamlessly integrating into the broader business structure to enhance our mission in the biotechnology industry.

What You’ll Do:

Collaborate on the preparation and authoring of aggregate safety reports for assigned products, such as PSURs, DSURs, and RMPs;
Lead the signal management process, including signal tracking and review meetings for assigned products;
Perform routine signal detection activities and author sections of signal evaluation reports;
Conduct comprehensive literature reviews for safety information and liaise with other departments to gather necessary data;
Partner with Global Safety Officers on investigational program activities, including protocol review and safety committee management;
Coordinate and author responses to safety queries from regulatory authorities for assigned products;
Contribute to process improvement initiatives to enhance aggregate reporting, clinical trial safety oversight, and signal management;
Independently lead and collaborate on substantive projects such as signalling, report authoring, and regulatory agency responses;
Mentor and guide less experienced PV Scientist staff;
Apply clinical judgment to interpret case information and contribute to safety evaluations;
Demonstrate familiarity with Pharmacovigilance and drug development processes, including clinical trial and post-marketing safety regulations;
Exhibit strong organizational skills and the ability to prioritize tasks with minimal supervision;
Utilize common data processing software and safety database systems proficiently.

Who You Are:

You have a robust scientific or healthcare background, passionate about patient safety and pharmacovigilance. You communicate complex medical data clearly and have a knack for collaborative teamwork. Your leadership skills shine in project management, and you have a talent for mentoring others. You possess clinical acumen and apply it adeptly in your work. Organized and independent, you navigate regulatory landscapes with confidence and are comfortable with technology, utilizing databases and software to streamline your tasks. You are seeking a role where your expertise and commitment to excellence will play a critical role in advancing healthcare solutions.

Qualifications:

Bachelor's Degree in biologic or natural science, or health care discipline (Advanced degree preferred, such as PhD, MPH, NP, PharmD, etc.);
Minimum 5 years of industry experience, with at least 3 years in pharmacovigilance (PV);
Ability to understand, interpret, analyse, and present scientific and medical data both verbally and in writing;
Strong interpersonal skills to work effectively in a team environment;
Experience leading projects in signalling, authoring reports, and responding to regulatory requests;
Clinical judgment in interpreting case information;
Familiarity with Pharmacovigilance and drug development, including clinical trial safety regulations and post-marketing safety regulations;
Strong organizational skills with the ability to prioritize independently;
Proficiency in common data processing software (EXCEL, PowerPoint, Microsoft Word) and knowledge of common safety database systems.