Senior PV Clinical Scientist - Hybrid

Aptask Global Workforce (AGW) is seeking a Senior PV Clinical Scientist - Hybrid for a 6+ month contract opportunity with a Global Biotechnology Company located in South San Francisco, CA.

This role performs tactical and operational responsibilities for the US Patient Safety team, including the collection, clinical review, evaluation, and processing of adverse event (AE) information. The successful candidate will contribute in-depth knowledge of Individual Case Safety Reports (ICSRs) case processing and work autonomously with minimal supervision.

Responsibilities:

• Complete drug safety monitoring and tracking in a timely, thorough and accurate manner in accordance with pharmacovigilance (PV) and related standards, regulations and company Standard Operating Procedures (SOPs)
• Review, evaluate, and verify potential AE information during triage to determine required action and perform data entry of adverse events
• Perform seriousness, validity, causality and quality review of all cases based on medical assessment
• Perform labeling assessment for AE(s) received using clinical knowledge and conduct follow-up for all reported cases
• Lead efforts to ensure quality of Individual Case Safety Reports (ICSRs) is at par with company standards
• Perform trend analysis of vendor case processing issues for assigned Therapeutic Areas (TA) and escalate as applicable
• Update and create SOPs and lead process improvement initiatives
• Ensure quality of Health Authority (HA) submissions is at par with local regulations
• Collaborate with departments and partners on drug safety data exchange
• Assist in AE reconciliation activities and/or Case Transmission Verification (CTV)
• Act as a Subject Matter Expert (SME) for safety-related activities and provide support during audits and inspections

Requirements:

• Health Care Professional degree (e.g., RN/BSN/MSN, NP, RPh/B Pharm/Pharm D, or MD)
• Thorough understanding of FDA safety regulations and submissions, ICH guidelines, and other applicable regulatory guidance documents, global PV regulatory environment, and EMA regulations
• Experience in science/medical writing
• Computer proficiency and data entry experience
• Strong project management skills
• Demonstrated capability to comprehend medical information and sound decision-making abilities
• Ability to work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
• Strong communication and presentation skills
• Ability to travel domestically and internationally as per business needs

Desired skills:

• Minimum 5 - 7 years of experience in a biopharma company with Pharmacovigilance responsibilities

Pay range: up to $65.18 per hour

Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position.

If you have the described qualifications and are interested in this exciting opportunity, apply today!

Aptask Global Workforce (AGW)
ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.

Benefits of working with ApTask Global Workforce include:

• Medical
• Dental
• Vision
• Sick Pay (for applicable states/municipalities)

Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website https://www.agwtalent.com/. 

ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.