PV Scientist

Biogen; Maidenhead; On-site; GBP 70,000 - 100,000; Full time

Job summary

Biogen in Maidenhead is seeking a PV Scientist to join our Pharmacovigilance team. You will perform signal management, author safety evaluations, contribute to aggregate reporting, and support regulatory responses, collaborating with clinical trial safety and global safety groups.

The role offers hybrid work with at least 50% on-site presence, reporting to a Senior PV Scientist, and opportunities to lead safety projects.

Qualifications

• Bachelor’s degree in biologic or natural science or health care discipline.
• Significant experience in Pharmacovigilance with pharmacovigilance signal detection (signalling) OR experience in medical device PMS.
• Proficiency in interpreting and presenting scientific data.
• Strong collaborative skills within cross-functional teams.
• Ability to lead substantive projects independently.
• Familiarity with Pharmacovigilance and drug development regulations.
• Strong organizational skills and ability to prioritize tasks independently.
• Basic knowledge of Excel, PowerPoint, Microsoft Word, and Business Objects.

Responsibilities

• Collaborate on preparation and authoring of aggregate safety reports for assigned products (PSURs, DSURs, RM Plans).
• Facilitate signal management processes, including signal tracking and safety data evaluations.
• Conduct safety literature reviews and interact with other groups to obtain data.
• Work with Clinical Trial physicians and Global Safety Officers on investigational programs, including protocol review and data analysis.
• Coordinate and author responses to safety questions from regulatory authorities.
• Contribute to process improvements regarding aggregate reporting and signal management.
• Serve as a Subject Matter Expert for global safety regulations and data analysis.

Skills

Scientific data interpretation

Pharmacovigilance experience

Team collaboration

Project leadership

Data processing tools

Pharmacovigilance regulations

Education

Bachelor’s Degree in biologic or natural science

PhD/MPH preferred

Tools

Excel

PowerPoint

Microsoft Word

Business Objects

Job description

About This Role

As a PV Scientist, you will be an integral part of our Pharmacovigilance team, reporting to a Senior PV Scientist. Your role will be pivotal in ensuring the safety and efficacy of our products by performing signal management activities and authoring comprehensive safety evaluations. You will contribute to aggregate report planning and authoring, handle ad hoc regulatory responses, and conduct safety literature reviews. You may serve as a lead or supporting PV Scientist depending on your assigned product or product groups. Your expertise will foster collaboration with clinical trial safety teams and ensure compliance with global safety regulations. This position is crucial in advancing our commitment to patient safety and maintaining our reputation for excellence in the biotechnology industry.

About This Role

As a PV Scientist, you will be an integral part of our Pharmacovigilance team, reporting to a Senior PV Scientist. Your role will be pivotal in ensuring the safety and efficacy of our products by performing signal management activities and authoring comprehensive safety evaluations. You will contribute to aggregate report planning and authoring, handle ad hoc regulatory responses, and conduct safety literature reviews. You may serve as a lead or supporting PV Scientist depending on your assigned product or product groups. Your expertise will foster collaboration with clinical trial safety teams and ensure compliance with global safety regulations. This position is crucial in advancing our commitment to patient safety and maintaining our reputation for excellence in the biotechnology industry.
This is hybrid role requiring a minimum of 50% on site office attendance per week in Maidenhead.

What You’ll Do

• Collaborate on the preparation and authoring of aggregate safety reports for assigned products, including PSURs, DSURs, and Risk Management Plans.
• Facilitate signal management processes, including signal tracking and conducting safety data evaluations for new signals.
• Conduct safety literature reviews and interact with other groups to obtain necessary data.
• Work with Clinical Trial physicians and Global Safety Officers on investigational programs, including protocol review and data analysis.
• Coordinate and author responses to safety questions from regulatory authorities.
• Contribute to process improvement initiatives regarding aggregate reporting and signal management.
• Serve as a Subject Matter Expert for global safety regulations and data analysis.

Who You Are

You possess a keen analytical mind and a strong understanding of scientific and medical data, allowing you to interpret and present complex information with clarity. Your collaborative spirit enables you to work effectively within cross-functional teams, ensuring seamless communication and teamwork. You demonstrate strong organizational skills, allowing you to prioritize tasks independently. Your familiarity with pharmacovigilance and drug development makes you an asset to our team. You bring a proactive approach to process improvement and consistently strive for excellence in all aspects of your work.

Required Skills

• Bachelor’s Degree in biologic or natural science or health care discipline.
• Significant experience within Pharmacovigilance in the Pharmaceutical or Biotechnology industry, with experience of pharmacovigilance signal detection (signalling) OR significant experience within the medical device / medtech industry, with experience in medical device post market surveillance (PMS).
• Proficiency in scientific and medical data interpretation and presentation.
• Strong collaborative skills within team environments and with external colleagues.
• Ability to lead substantive projects independently and collaboratively.
• Familiarity with Pharmacovigilance and drug development regulations.
• Strong organizational skills and ability to prioritize tasks independently.
• Basic knowledge of common data processing software (Excel, PowerPoint, Microsoft Word, Business Objects).

Preferred Skills

• Advanced degree (PhD, MPH, NP, PharmD, etc.).
• Experience with safety database systems.

Job Level: Management

Why 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.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.