Pharmacovigilance Oversight Manager - Contract - Boston, Remote
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天博体育 is seeking a Pharmacovigilance (PV) Planning Specialist for a fully remote role.
Primary Responsibilities:
In this position, you will support safety-related activities across all stages of clinical development, including late-stage compounds. You will collaborate with internal teams, external partners, and vendors to ensure compliance with global regulations and timely delivery of pharmacovigilance deliverables. This role requires a proactive approach to problem-solving and effective communication with cross-functional teams.
Skills & Requirements:
- Bachelor's degree in life sciences (e.g., Biology, Pharmacy, Nursing) or equivalent; an advanced degree is preferred.
- Experience in pharmacovigilance/drug safety, with demonstrated success in managing and completing Phase I-IV clinical programs.
- Strong understanding of global regulations and compliance requirements related to pharmacovigilance.
- Proven ability to work on complex projects and deliver results within defined timelines.
- Excellent communication and collaboration skills to interact with cross-functional teams and external partners.
The Pharmacovigilance Oversight Manager's responsibilities will be:
- Act as the primary liaison for internal and external stakeholders regarding GPS deliverables in clinical programs, supporting Phase I-IV studies.
- Manage clinical program GPS deliverables independently, ensuring compliance with SOPs, alliance partner agreements, and global regulations.
- Support PV Planning deliverables, including preparation of line listings and SAE reconciliation listings for periodic reports or clinical studies.
- Analyze diverse data sets to identify solutions and determine appropriate courses of action.
- Collaborate with clinical teams, CROs, and alliance partners to manage pharmacovigilance deliverables effectively.
- Contribute to organizational projects and goals, ensuring alignment with company objectives.
Compensation:
If you are having difficulty in applying or if you have any questions, please contact Bo Forsen at b.forsen@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
天博体育 is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. 天博体育 is acting as an Employment Agency in relation to this vacancy.
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