MSI are looking for Drug Safety Specialist to join a well known Biotech company based in the US. If you have any experience with ICSR's, case processing and working on a safety database and are looking for a change, then this role may be for you.

Responsibilities:
· Works with direct manager and other Global Patient Safety team members to execute submissions processes for generating, submitting, and tracking expedited individual case safety reports and aggregate safety report submissions to regulatory authorities and other applicable recipients for investigational and marketed products.
· Assists with oversight of safety vendor activities.
· Assists with monitoring tasks to ensure CRO compliance with global regulations
· May assist in the development and training of department-specific SOPs and Work instructions to ensure procedures are in place to support a global submissions process.
· May collaborate with the BeiGene Safety Systems team to ensure the global safety database can support submission processes.
· May analyze submissions metrics and trends to provide data driven strategic recommendations to the Global Safety Submissions lead.
· Provides support to Contract Research Organizations (CROs) involved in safety reporting to local regulatory authorities.
· May support PV regulatory inspections (FDA, MHRA, CFDA, etc.) and/or partner audits

Competencies:
· Ethics- Treats people with response, Inspired the trust of others; Works with integrity and ethically Upholds organizational values.
· Planning/Organization- Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.
· Communication- Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.
· Teamwork- Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a s positive team spirit; Puts success of team above own interests; Supports everyones efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.
· Adaptability - Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.
· Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.
· Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
· Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
· Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.
· Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.
· Project Management - Communicates changes and progress; Completes projects on time and budget.

Education, Skills and Experience:
· Proficiency with Microsoft Suite of products and Adobe Acrobat. Skills in Microsoft Project, Microsoft Visio, Microsoft SharePoint and Veeva a plus
· Strong analytical skills & preferably experience with Argus safety database, MS Excel, Spotfire, Tableau or other tools used to summarize PV compliance metrics
· Ability to handle multiple projects at once, and to accommodate meetings scheduled globally (e.g.; US, EU, Asia/Pacific and/or Latin American regions)
· Knowledge of Oracle Argus safety database workflows is strongly preferred.
· Previous experience and understanding of pharmacovigilance, regulatory affairs, clinical research and/or compliance preferred.
· Strong attention to detail and the ability to multi-task in a fast-paced environment
· Strong interpersonal and communication skills and the ability to effectively work individually, within a cross-functional team, as well as with external partners, vendors and overseas colleagues.
· Associate or bachelors degree required with at least 1-2 years of relevant experience within the healthcare industry