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Senior Medical Director, Product Safety, Pharmacovigilance, and Risk Management - Maryland, United States - Poseida Therapeutics, Inc.
Description
Please note that while this position has been designated as remote based the position will be required to observe Pacific hours.
As Senior Medical Director, Product Safety and Risk Management you will have the opportunity to collaborate with an experienced and tight knit Clinical Development, Clinical Operations and Regulatory team.
In this role you will have the unique opportunity to lead the safety and pharmacovigilance function in support of Poseida's oncology cell therapy programs.
The Senior Medical Director, Product Safety, Pharmacovigilance & Risk Management will be responsible for the safety, pharmacovigilance (PV) and medical monitoring activities of multiple clinical trials and potentially multiple clinical programs, and will also participate in the development of, clinical development plans, clinical trial protocols, data analyses, clinical study reports, investigator brochures and other clinical and regulatory documents.
The position will be involved with pre-marketing clinical trials. This individual will have a broad understanding of internal medicine, oncology and clinical pharmacology.The position will entail opportunities to be the external "face" of the company in interactions with investigators, regulatory authorities, contract research organizations (CRO) and development partners.
This individual will require strong leadership capabilities and a vision to build a world-class safety reporting, and pharmacovigilance function.Accountable to build a world-class safety function
Leads and oversees ongoing medical and safety monitoring of Poseida's partner and investigational cell therapy products, including overseeing trending assessment and safety signal detection
Leads all Poseida led or sponsored clinical trials safety reporting including assuring all trials have a plan in place including, as needed, a formal pharmacovigilance plan
Accountable to assure all safety reporting requirements are met. In support of this will work closely with regulatory team and CRO
Generates, authors, and/or reviews product safety reports as required by the worldwide regulatory agencies by developing safety data retrieval strategy and assessing the significance of relevant safety information
Leads investigational drug and post-marketing pharmacovigilance, working in conjunction with the CROs, including the generation of narrative and completion of medwatch forms and the authorship of Periodic Safety Update Reports
Assures timely completion of all risk assessments as part of the Risk Management Plan for all products and make recommendations to the core safety and product labeling as part of the fulfillment of the Pharmacovigilance function, The risk assessment will follow the guidance documents from applicable regulators.
Interfacing with external key opinion leaders, advocacy groups and advisory boards, representing the safety functionOversee the development, approval and issuance of drug core information and informed consent documents and recommend changes from scientific inputs when necessary.
Oversee development of product risk/benefit or health hazard analysis and assessment to aim appropriate regulatory actions for drug safety and/or quality issues.
MD/DO degree required, preferably with post-graduate, broad-based specialty training (e.g., internal medicine, oncology, specialty)Minimum of 5 plus years of applicable industry experience in a biotechnology or pharmaceutical company in a job position performing many or most of the responsibilities in this job description, preferably in a fast-paced, dynamic environment
Extensive external networks within the oncology therapeutic area. Previous experience within cell therapy desired.
Intimate knowledge of and high level expertise in the day-to-day medical monitoring of clinical trials (e.g., review of safety parameters; and IND expedited safety reports)
Knowledge and expertise in pharmacovigilance, including the receipt and processing of ADRs, narrative composition/editing, classification of safety events, completion of MedWatch forms, and generation of Periodic Safety Update Reports
Demonstrated experience and expertise in the primary authorship of multiple clinical trial protocols, design of case report forms and the design of clinical data listing and tables for clinical trials
Preferable to have demonstrated experience and expertise in the primary authorship of clinical study reports, including oversight of the generation of tables, figures and listings from the study database
Ability to juggle multiple projects at the same time, with good time management skills and the ability to prioritize appropriately.
Travel anticipated up to 10% of time.Senior Medical Director, Product Safety, Pharmacovigilance and
Risk Management Pay Rate:
$312,000 to $342,000
Based in San Diego, Poseida Therapeutics is a clinical-stage biopharmaceutical company utilizing our unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure.
We are passionate about making an impact on patients' lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases.
Our team is passionate about improving patients' lives through innovation. As we advance our compelling pipeline, there are endless opportunities for impact and growth. Recruitment Fraud AlertThese scams have appeared in forms of false job advertisements and/or unsolicited contacts via communication/chat platforms, phone, email or text from individual(s) claiming to be or represent Poseida's Human Resources team.
please visit our official careers website or official Poseida Therapeutics LinkedIn page .Job postings that do not link directly to our careers website or official Poseida LinkedIn page are not legitimate and might be fraudulent.
If you have been defrauded or suspect identity theft as a result of an employment scam, please contact your local law enforcement agency for guidance.
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