Medical Director, Drug Safety & Pharmacovigilance
Responsible for medical safety oversight and monitoring of MEI drugs, either managed internally or outsourced to vendor(s). Assure activities are completed accurately in accordance with the world-wide regulatory requirements, master service agreement, quality agreement and applicable statement of work. Assist the Head of Drug Safety with the maturation and further development of the medical -safety sub function of the DSPV department at MEI, taking on the role of Drug Safety Medical Expert on MEI compounds.
This position will Safety Management Team(s) (SMT) review safety reports; and assist the Head of DSPV in provision of Good PVG mediated guidance. This direction may be given to project development teams for safety-related areas including protocol development, updates to investigators brochures, informed consent forms and study conduct as required.
This position will collaborate with DSPV consultants; the successful candidate will eventually manage some physician direct reports.
Role & Responsibilities:
- Responsible to implement and maintain policies, processes and procedures to ensure compliance with FDA and international regulations and guidance
- Provide safety training as needed and eventually develop and managed SDPV s.
- Maintain medical safety status reports, keep Head of DSPV apprised of any potential/actual product safety issues, and assist with developing solutions
- Assure all product specific medical safety activities are completed in accordance with SOPs, SSPs, and other applicable regulations
- Leads one or more Product specific SMTs and assists Head of DSPV with Safety Governance
- Comprehensive knowledge of EMA, FDA PV regulations as well as GPV rules/practices
- Familiarity with PMDA regulations a plus
- Excellent written and verbal communication skills.
- Positive attitude and ability to interact with all levels of staff to successfully coordinate and execute Medical Safety oversight for assigned products.
- Excellent organization skills, time management skills, and ability to handle multiple priorities while adhering to applicable timelines.
- Ability to work independently, follow instructions/guidelines and demonstrate initiative with minimal oversight.
- Strong knowledge of the clinical research process and current GCP/ICH guidelines applicable to conduct of clinical research.
- Demonstrates professionalism and presents a positive image of the company.
- Demonstrates commitment, dedication, cooperation, positive behavior, adaptability and flexibility with changes in responsibilities and duties.
- Demonstrates honesty and integrity in dealing with others. Works effectively with different types of people. Accepts constructive feedback without becoming defensive.
- Establishes and maintains effective relationships with customers (internal and external) and gains their trust and respect.
Education and Experience:
- A minimum of 5 years of experience in Drug safety and Pharmacovigilance in the industry (biopharma and/or CRO)
- Medical/ degree, ideally with completion of residency training program
- Prior experience with mentoring/training of staff
- Demonstrated competency within ARGUS,
- Computer literacy and experience working with Microsoft Office (Word, Excel) required