Job Description
Reporting to the Chief Medical Officer, the
Sr. Medical Director, DSPV will be responsible for providing scientific and risk management expertise in support of Client’s development compound(s). This position holds the primary responsibility for medical review of individual case safety reports which include confirmation of MedDRA coding, assessments (seriousness and expectedness), case queries, and analysis of similar events as needed. The position will also function as an interdepartmental project lead in the handling and analyses of safety data from clinical trial data and literature reports. The Safety Physician is a key contributor working closely with both internal and external Safety staff, as well as with cross-functional teams such as Clinical Development, Clinical Operations, Biometrics, Medical Writing, Regulatory Affairs, and other multi-disciplinary teams and committees contributing to signal detection and to the risk evaluation and management of safety data.
THE RESPONSIBILITIES The major duties and responsibilities will include but are not limited to the following:
- Provides medical reviews for SAEs, SUSARs, and other Safety reports to include case assessments and input to Analysis of Similar Events as required.
- Oversees the Safety Review Committee in collaboration with internal and external cross-functional teams.
- Participates in the presentation and discussion of safety data at Data Safety Monitoring Board meetings.
- Contributes to the preparation and review of the safety sections of the Drug Safety Update Reports (DSURs), Investigator Brochure (IB)/Reference Safety Information, clinical trial protocols and final reports, the informed consent form (ICF), and safety reporting forms.
- Contributes to the development and/or reviews of SOPs.
- Leads and/or supports signal detection and literature review activities.
- Contributes to regulatory submission documents, interactions with global regulatory agencies and/or external stakeholders, and health authority requests.
- Participates in the MedDRA coding review of reported (non-serious) adverse events.
- Ensure patient safety while adhering to the highest quality and ethical standards.
THE QUALIFICATIONS - Medical Degree (MD or equivalent) required
- 8+ years of medical safety experience (Safety Science/Risk Management) gained in Pharmacovigilance, Clinical Research, or Clinical Development within the Pharmaceutical industry.
- Experience operating in a global pharmacovigilance organization strongly preferred.
- ICSR Medical Review experience including knowledge of MedDRA and WHODrug coding dictionaries.
- Extensive signal detection/risk management experience with knowledge of biostatistical methods used in drug development and Safety surveillance, analysis and reporting.
- Working knowledge of ICH, US and worldwide Safety reporting regulations and requirements.
- Expertise in or exposure to therapeutic areas (Hepatology and/or Endocrinology) is a plus but not required.
- Strong organizational, project management, and leadership skills.
- Excellent written and verbal communication skills.
- Ability to work in the SF office two days a week (Tuesday & Wednesday)
Job Tags
Worldwide, 2 days per week,