Job Description
About This Role:
You will be a pivotal member of our safety and pharmacovigilance team, responsible for managing and executing safety-related tasks for designated products or product groups. Your multifaceted role includes performing vital signal management, crafting meticulous safety evaluations, and overseeing aggregate report authoring.
Key Responsibilities:
1. Collaborate on the preparation and authoring of aggregate safety reports for assigned products, such as PSURs, DSURs, and RMPs.
2. Lead the signal management process, including signal tracking and review meetings for assigned products.
3. Perform routine signal detection activities and author sections of signal evaluation reports.
4. Conduct comprehensive literature reviews for safety information and liaise with other departments to gather necessary data.
5. Partner with Global Safety Officers on investigational program activities, including protocol review and safety committee management.
6. Coordinate and author responses to safety queries from regulatory authorities for assigned products.
7. Contribute to process improvement initiatives to enhance aggregate reporting, clinical trial safety oversight, and signal management.
8. Independently lead and collaborate on substantive projects such as signalling, report authoring, and regulatory agency responses.
9. Mentor and guide less experienced PV Scientist staff.
10. Apply clinical judgment to interpret case information and contribute to safety evaluations.
11. Demonstrate familiarity with Pharmacovigilance and drug development processes, including clinical trial and post-marketing safety regulations.
12. Exhibit strong organizational skills and the ability to prioritize tasks with minimal supervision.
13. Utilize common data processing software and safety database systems proficiently.
Requirements:
* 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.
Preferred Skills:
* Advanced degree in a relevant field.
* Experience in mentoring.
About Biogen:
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.