Senior Safety Surveillance Manager
1 week ago
Position Overview:
Clinical Resource Network (CRN) is seeking an experienced professional for the role of Associate Director of Safety Surveillance. This position offers the flexibility of remote work, allowing you to contribute to our mission from anywhere.
Key Responsibilities:
- Prepare comprehensive aggregate safety reports.
- Work closely with Medical Directors within the Drug Safety and Pharmacovigilance (DSPV) team.
- Organize and facilitate safety review meetings.
- Engage in signal detection activities, focusing on the identification and management of safety signals.
- Draft Drug Safety Update Reports (DSURs), Periodic Adverse Drug Experience Reports (PADERs), IND Annual Reports, and other global safety reports as required by health authorities.
- Contribute to the safety sections of critical documents such as Investigator Brochures (IBs), study protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and Risk Management Plans (RMPs).
- Summarize safety findings in product safety reports.
- Support the assessment and detection of safety signals.
- Identify and validate potential trends and concerns regarding both company and competitor products.
- Conduct literature surveillance to monitor published medical literature.
- Review Tables, Figures, and Listings (TFLs) and Adverse Event (AE) data to assess common AEs and laboratory abnormalities.
Qualifications:
- A minimum of a Bachelor's degree is required.
- At least 5 years of experience in pharmacovigilance within a pharmaceutical or biotechnology environment, covering both pre- and post-approval activities.
- Experience in US and global pharmacovigilance practices.
If you possess the necessary qualifications and are interested in this opportunity, we encourage you to consider joining our team.
About Clinical Resource Network (CRN):
Established in 2002, CRN, a division of Solomon Page, specializes in providing clinical research and talent solutions tailored for the pharmaceutical, biotech, and medical device sectors. Our focus is on building long-term partnerships, offering services that include contract staffing, project staffing, consultative services, and full-time placements. For further information, please visit our website.
Join Us:
We look forward to the possibility of welcoming you to our team.
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