Senior Pharmacovigilance Leader
22 hours ago
Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect professionals with opportunities in pharma, biotech, health sciences, healthtech, and IT domains.
Salary
The estimated annual salary for this position is $90,000 - $100,000.
Job Description
We are seeking an experienced Associate Director to lead our pharmacovigilance operations. This role will be accountable for developing and executing global processes and deliverables.
This position plays a critical role in supporting ongoing clinical trials and vendor oversight. You will partner with key stakeholders to ensure harmonized operations of global pharmacovigilance activities and maintain the highest standards.
You will report to the VP and Head, Clinical Development, and be responsible for overall leadership to support global principles and standard practices for pharmacovigilance operational activities within clinical trials and post-marketing support.
This includes leading and/or editing/reviewing safety sections of SMPs, Investigator Brochures, DSUR, Protocols, Informed Consents, and related Safety Documents to ensure Regulatory, GCP, and Legal compliance.
Additionally, you will oversee CROs responsible for DSPV-SAE reporting to Authorities and generate periodic safety reports.
Collaborate in regulatory inspection preparedness/audit readiness, with a focus on U.S. and EU/EMA Regulations.
Assist in Safety Database set-up and performance, including database validation checks.
Participate in DSPV or Clinical audits of CROs/vendors.
Collaborate in related Biometrics processes, such as performing DMP reviews, IDMC Charter reviews, attending DMC meetings, performing eCRF and CCG reviews, SAE Reconciliation, etc.
Provide DSPV advice and guidance to other functional groups as needed.
Interface with other functional groups to ensure harmonization of processes and data collection/content as needed.
Attend meetings, such as DSPV meetings with CROs/vendors, DMC meetings.
This role requires a minimum of 8+ years of related job experience and completion of an undergraduate degree in a scientific discipline.
A minimum of 8+ year of related job experience is required for this position.
Knowledge of FDA, EMA, and other Regulatory adverse event reporting regulations and demonstrates the ability to interpret and apply applicable regulations to resolve safety issues.
Excellent oral and written communication skills and interpersonal skills; strong collaboration and leadership skills; expert scientific knowledge; organization and time management skills; strategic thinking and influencing skills.
Vendor oversight, stakeholder management, and demonstrated complex problem-solving ability and sound judgment ability.
Medical and technical writing experience.
Ability to work in a complex and evolving environment.
Ability to travel to support company meetings up to 10%.
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