Description
DESCRIPTION:Medical Safety Scientist, Drug Safety Evaluation will be responsible for writing clinical expert statements, benefit risk summaries, safety assessments and safety reports. This person would serve as a supportive role to medical affairs safety function, and participate in Safety Review Team meetings, Area Quality Review team meetings and Risk Management meetings.
RESPONSIBILITIES:
Assist in development and evaluation of safety risks, safety assessments and Health Hazard Assessments; Assist in preparation of benefit/risk assessment documents in support of new product registrations or in support of currently marketed products; Participate in Safety Review Team meetings, and Core Datasheet Assessment Team meetings; Prepare responses to queries relevant to the safety of products from affiliates and other internal functional groups.
QUALIFICATIONS:
Pharmacist, nurse, or equivalent, 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:
Pharmacist, nurse or other equivalent HCP with at least 1-2 years experience in safety, and medical and safety writing experience; 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.
Candidates MUST be able to complete an initial 6-month assignment. Extension past this time is likely but not guaranteed. No OT, No Travel required. All work to be performed onsite in Madison, NJ.
SKILLS
Quality Assurance, Quality Control
Synectics is an Equal Opportunity Employer.