Pharmacovigilance and Regulatory Safety Leader
1 week ago
Job Title: Pharmacovigilance and Regulatory Safety Leader
We are seeking an experienced Pharmacovigilance and Regulatory Safety Leader to join our team at Lifelancer, a leading talent-hiring platform in Life Sciences, Pharma and IT.
The ideal candidate will have a strong background in pharmacovigilance and regulatory affairs, with experience in managing safety profiles of new drugs, devices, and interventions in clinical trials.
Key Responsibilities:
- Monitor CRO/business partner activities to ensure adherence to Safety Monitoring Plans, study plans, KPIs, and contractual agreements
- Serve as SME for PV compliance, inspection readiness, and safety management topics
- Provide operational leadership for ICSR workflows and oversee case management in Argus or other safety databases
Requirements:
- Bachelor's Degree in a Science or related field required; advanced degree (PharmD, MD, etc.) strongly preferred
- Experienced in drug safety/pharmacovigilance role in the biotech/pharmaceutical industry and/or in a CRO or clinical trial setting
- Familiarity with and ability to effectively utilize safety databases needed. Knowledge of Argus Safety Database in an administration capacity is preferred
What We Offer:
- An estimated annual salary range of $85,000-$110,000, depending on experience and qualifications
- A comprehensive benefits package, including medical, dental, and vision insurance, short-term disability insurance, life insurance, voluntary long-term disability insurance, 401K safe harbor plan, paid vacation, holiday, sick, and volunteer time, and paid maternity & paternity leave
About Us:
Lifelancer partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. Our company has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.
Our Services Include:
- Expanded Access Programs (EAPs)
- Named Patient Programs (NPPs)
- Clinical Trial Supplies (Comparator & Ancillaries)
- Wren Nursing (Clinical Trial Home Nursing & Clinical Education)
- Hospital Supply of Unlicensed Medicines
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