Associate Medical Director
2000 Sierra Point Parkway Suite 600 Brisbane, CA 94004
Bayside Solutions is seeking an Associate Medical Director to be part of our client’ s team in Brisbane. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Associate Medical Director
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- Perform medical review of pre- and post-marketing individual case safety reports (ICSRs) and/or aggregate safety data products to ensure accuracy of ICSR MedDRA coding, assessments of seriousness, expectedness, causality, and regulatory reporting
- Participate in the preparation and maintenance of Reference Safety Information (RSI), periodic reports and associated product labeling (e.g., Company Core Safety Information (CCSI), Investigator Brochure (IB), national labels, Informed Consent (ICF), Periodic Safety Update Report (PSUR) for marketed and investigational products), clinical study reports/synopses, New Drug Application (NDA)/Biologics License Application (BLA)/Common Technical Document (CTD) submissions, Risk Management Plans and other documents as needed
- Participate in Safety Management Team (SMT) and Product Safety Committee (PSC) meetings
- Support study teams (clinical and registry) for assigned investigational and marketed products; serve as PV expert and liaise with Clinical Sciences, Clinical Operations, Medical Affairs, Biometrics, Regulatory Affairs, Contract Research Organizations (CROs), Data Monitoring Committees (DMCs) and other entities as needed
- Contribute to the production and/or contribute to health authority and other safety related query responses
- Provides input to Pharmacovigilance policies and standard operating procedures.
- Able to mentor and coach others at more junior levels
- Other duties as assigned.
Summary of Qualifications:
- Degree in Medicine, Pharmacy or Nursing (MD, DO, PharmD, PhD)
- Pharmaceutical industry background and proven competence in PV preferred.
- Minimum of 2 years of Pharmacovigilance experience; with previous signal detection/safety surveillance and international experience preferred.
- Minimum 1 year medical/clinical experience post- graduate training
- Experience reviewing cumulative safety data with ability to interpret, synthesize and communicate complex clinical /pharmaceutical information and safety data to both healthcare professionals (HCPs) and non-HCPs Thorough understanding of the drug development process and context applicable to safety surveillance activities
- Working knowledge of global PV requirements (e.g., US Code of Federal (CFR) regulations; European Union (EU) Volume 9A and Volume 10 clinical trials directive; Guideline on Good Pharmacovigilance Practices (GVP) and ICH Guidelines)
- Knowledge of MedDRA terminology and its application
- Experience in the preparation and authoring of pre- and post- aggregate safety reports, RMPs, and RSI
- Thorough understanding of the drug development process and context applicable to safety surveillance activities
- Excellent verbal and written communication skills as well as presentation and team-interaction skills are necessary
- Strong time management, prioritization, organizational and multitasking skills are required
- Excellent interpersonal, team management and leadership skills
- Proficiency in Microsoft Office and experience with safety databases; Argus experience is a plus