Description: Our client who is working on CNS/psychiatric disorders is currently seeking a Sr, Manager/AD - PV and Safety
POSITION RESPONSIBILITIES:
Accountable for global oversight of drug safety processes and compliance, and drug safety deliverables.
Provides detailed, accurate and timely medical review of aggregate and/or individual clinical trial and post-marketing adverse event reports (AERs).
Performs signal detection using the medical literature and relevant medical databases, as appropriate.
Medically reviews individual case study reports from clinical trials, as well as evaluates all relevant cases in depth, including MedDRA coding.
Performs regulatory assessment for expectedness and seriousness of AEs.
Oversees the delivery of Periodic Adverse Drug Experience Reports.
Accountable for SAE narrative generation; SAE database; and investigator alerts for clinical trials.
Ensures timely and appropriate drug safety contributions to NDA periodic reports.
Oversees the regular review of NDA safety data with respect to safety label updates and modifications.
Directs the creation and maintenance of company core safety information.
Reviews and approves safety sections of all clinical study reports (CSRs) (including interim as well as final reports).
Oversees the preparation of NDA documents, specifically the Integrated Summary of Safety (ISS) or equivalent document, and all safety related review comments or questions.
As needed, Develops and oversees Risk Minimization Plan (RMP) and/or Risk Evaluation and Mitigation Strategy (REMS).
Collaborates with cross functional team to develop Risk Assessment Plan, with continued monitoring throughout the development and life cycle activities.
Oversees development, implementation and reporting of pharmacoepidemiology studies when needed.
Responsible for the safety agreements with DR&PV vendors and clinical trial CROs.
Contributor to key clinical and regulatory documents such as Investigator Brochures (IBs), IND packages, and other safety documents to support CTAs, NDAs or Annual Reports.
Stays informed of new safety regulations and guidance from the regulatory authorities.
Manages pharmacovigilance provider; supports vendor identification and contracting as required.
CANDIDATE REQUIREMENTS:
Advanced Life Science degree required
A minimum 7 years combined in pharmacovigilance and clinical research/clinical safety experience in the pharmaceutical industry.
Ability to synthesize and analyze safety data from various sources. Proficiency in problem-solving within a highly complex environment.
Knowledgeable in international regulations governing drug safety.
Experience in managing compliance or audits. Working knowledge of relevant FDA, EU, ICH guidelines, initiatives and regulations governing both Safety reporting and processing.
Strong communications skills, both written and spoken, ideally with demonstrable experience in medical / scientific writing.
Contact: arawat@judge.com
This job and many more are available through The Judge Group. Find us on the web at www.judge.com
