About This Role
As a Clinical Trial Management PV Lead, you will play a pivotal role in ensuring the operational excellence and strategic oversight of safety processes, contents and data quality within clinical studies. Positioned within our pharmacovigilance team, this role is integral to maintaining compliance with global safety regulations while driving innovation in safety data review and management practices. From utilizing tools and processes for safety database configurations to leading quality reviews of Individual Case Safety Reports (ICSRs), you will be instrumental in shaping our clinical safety initiatives. Your expertise will support cross-functional collaborations, enhance safety data quality, and contribute to regulatory filings and ongoing safety surveillance and risk management activities. As a senior leader in the team, you will identify areas for improvement within the pharmacovigilance system, lead strategic initiatives, and contribute to the development and update of procedural documents. This position offers an exciting opportunity to work at the intersection of clinical development, pharmacovigilance, and regulatory compliance, making a meaningful impact on patient safety and clinical trial success.
What You’ll Do
- Responsible for safety operational processes and strategic content pertaining to clinical studies such as protocols, ICFs, CRFs, safety management plans, study forms, CSRs, SAPs ; tools and processes for safety database requirements and configurations to enable safety-related activities during studies;
- Responsible for developing training requirements and materials for clinical trial safety data reporting and collection (e.g. Investigator meetings, Site Initiation Visit),
- Support clinical trial safety report collection and collaborate with other functions (e.g., Clinical Operations, Data Management, Regulatory, Biostatistics, and others) to ensure consistency with regulations and study objectives
- Lead the quality review of ICSRs and oversee the KPIs pertaining to data quality
- Lead data quality related root cause analysis, QE investigation and CAPA management
- Lead the safety data review and analysis of clinical studies and support ongoing safety surveillance activities, aggregate reports (DSUR, SUSAR LLRs), development of safety contents in CSRs and regulatory filings (e.g. BLA, MAA)
- Contribute to business alliance management pertaining to relevant clinical studies
- Review and archive PV related records in various documentation management systems (e.g. TMF)
- Identify gaps and areas of improvement within the PV system and lead strategic initiatives to address them
- Develop, maintain and implement PV related procedural documents (e.g. SOPs)
Required Skills
- Bachelor’s degree in a biological or natural science, or health care discipline (e.g. nursing, pharmacy).
- Eight (8)+ years of pharmacovigilance and GCP experience required
- Extensive experience in case processing (data entry, QC, coding) and handling of ICSRs including submissions and exchanges in both clinical trial and post-marketing settings required
- Hands-on experience in clinical study documents (e.g. protocols, ICFs, CSRs)
- Proficient in Argus
- Understanding of global safety reporting regulations and guidelines including the FDA, ICH, and EU Regulations and Requirements for Pharmacovigilance
- Strong analytic and organizational skills, including the ability to handle complex tasks, prioritize effectively, and project management initiatives/process improvements.
- Strong computer skills within Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
- Knowledge of medical and clinical practices and a strong understanding of medical concepts and terminology required
- Demonstrated ability to work proactively and independently with minimal oversight needed by management.
Preferred:
- Hands-on experience in supporting NDA/BLA/MAA filings and responses to Health Authorities Queries required
- Advanced Degree (M.D., Ph.D., MPH, NP, PharmD, etc.)
- Hands-on experience in aggregate safety reports (e.g. DSUR, PBRER, SUSAR LLRs) preferred
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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 our DE&I efforts.
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.
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