Biogen · 2 weeks ago
Clinical Trial Management PV Lead
United States
Full-time
Remote
Senior Level, Lead/Staff
$134K/yr - $179K/yr
8+ years expBiogen is a mid-sized biotechnology company committed to excellence and innovation. The Clinical Trial Management PV Lead will ensure operational excellence in safety processes and maintain compliance with global safety regulations, playing a crucial role in clinical safety initiatives.
BiotechnologyHealth CareNeuroscienceTherapeutics
Responsibilities
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)
Qualification
Required
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
Benefits
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
Company
Biogen
Biogen is an American biotechnology company that provides therapeutics for neurological, autoimmune, and rare diseases.
Founded in 1978Cambridge, Massachusetts, USA
5001-10000 employees
H1B Sponsorship
Biogen has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (100)
2024 (93)
2023 (101)
2022 (134)
2021 (104)
2020 (114)
Funding
Current Stage
Public CompanyTotal Funding
$1.5BKey Investors
JP Morgan
2023-08-28Post Ipo Debt· $1.5B
1991-09-27IPO
Leadership Team
Robin C. Kramer
Executive Vice President, Chief Financial Officer
Priya Singhal
Executive Vice President, Head of Development
Recent News
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