Associate Manager - Drug Safety & Public Health

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05 Aug 2017
16 Aug 2017
Job Title: Associate Manager - Drug Safety & Public Health Job Type: Contract (18 Months) Job Location: Cambridge Job Description Specific Responsibilities: - Signal detection and authorship of signal work-up documents in collaboration with a safety physician. - Authorship of CCDS sections and associated supporting documentation. - Authorship of aggregate safety reports (e.g., PSURs). - Authorship of risk management plans. - Authorship of responses to regulatory agency safety enquiries. - Contributes to safety analyses in Regulatory submissions (e.g., MAAs, NDAs). - Reviews global literature for identification of individual case safety reports and potential safety concerns. - Performs safety review of clinical trial protocols, investigator brochures, study reports, informed consent forms, and other study related documents for assigned studies. - Reviews standard reference documents and develops listedness/expectedness tables in collaboration with a safety physician. Essential Duties and Job Functions: - Work is performed under close supervision following established procedures. - Develops basic knowledge of pharmacovigilance, regulations, aggregate safety reports, risk management plans, signal detection, clinical trials, and clinical development. - Demonstrates ability to present results and findings and discuss processes in formal settings, including Clinical Development Team, Study Management Team, and Product Safety Committee meetings. - Shows ability to effectively collaborate with cross-functional staff. - Communicates effectively to ensure relevant parties are fully informed and knowledgeable of project activities and their status. - Begins to establish recognition within the job family as a technical expert. - Familiar with searching drug safety and literature databases for relevant information. - Contributes to safety committee meetings (internal or with partner companies). - Participates as a member of various cross-functional teams, including participation on Clinical Development Teams involving interaction with Medical Monitors, Clinical Scientists, Clinical Operations, and other Medical Affairs personnel. - May act as a mentor to employees with less experience. - May lead projects with supervision. Knowledge, Experience, and Skills: - Typically requires a degree (e.g., BS, BA, MSc or PhD) or professional qualification in a health science field (e.g., nursing or pharmacy) or a relevant scientific/technical discipline (e.g. biology, chemistry, or neuroscience). - Some experience (2 years) in the pharmaceutical industry, at a regulatory agency, or in clinical research is preferred. - Demonstrates a good level of competency in verbal and written communication, including Microsoft Excel, Office, Word, and PowerPoint. - Demonstrates good analytical thinking skills, attention to detail, teamwork, initiative, and basic project management skills; maintains confidentiality; maintains meticulous attention to project deadlines.