Description
SUMMARY: Medical Safety Manager, Drug Safety Evaluation will be responsible for preparing benefit/risk assessments in support of new product registrations or of currently marketed products. This individual serves as a supportive role to PCH medical affairs safety function, and participates in Safety Review Team meetings, Area Quality Review team meetings and Risk Management meetings.
RESPONSIBILITIES: Development and evaluation of safety risks, safety assessments and Health Hazard Assessments; Prepare benefit/risk assessment documents in support of new product registrations or in support of currently marketed products; Prepare benefit risk summary/or review periodic safety reports (PSURs, U.S Annual Safety Reports) in accordance with regulatory requirements; Participate in ongoing safety surveillance and signal detection/analysis, including aggregate data review/trend analysis; Evaluate, interpret, synthesize safety data, which includes experience in preparing safety assessments, risk/benefit evaluations and regulatory reports; Participate in Safety Review Team meetings, and Core Datasheet Assessment Team meetings; Prepare responses to queries relevant to the safety of products from PCH-affiliates and other internal functional groups.
QUALIFICATIONS: Nurse RN/BSN or equivalent, ideally with experience in drug development, clinical pharmacology, and/or pharmacoepidemiology within the pharmaceutical industry, regulatory agencies or academia; Knowledge of US and international regulatory/safety regulations and guidelines; Experience working with the safety databases; Strong organizational skills and ability to prioritize multiple projects and meet deadlines; Proven scientific writing skills and good communication skills; Risk management expertise, understanding of pharmacovigilance practices, particularly in relation to signal detection and evaluation; Demonstrated writing skills (regulatory documents, etc.); Specific experience with analgesics, respiratory, nutritional supplements, devices and/or dermatological products is a plus.
MOST CRITICAL SKILLS NEEDED ARE: Nurse with at least 5-6 years experience in safety; Resourceful; can-do attitude; someone who takes immediate actions to drive resolution to an issue; problem solver; ability to work independently once trained; a team player.
SKILLS
MS Excel, MS Outlook, Licensed Registered Nurse (RN)
Synectics is an Equal Opportunity Employer.