Remote Safety Risk Management Lead

Duties:

Serves as a creator/contributor for signal detection and product safety scientist tasks.

• Leads and performs safety signal management activities including detection, validation, prioritization, evaluation, confirmation or refutation, and the tracking of risk mitigation and minimization actions using Oracle Empirica Signal and Topic.

• Performs ongoing review of emerging safety data from various sources including individual case safety reports, published literature, aggregate reports, and other sources.

• Effectively lead, oversee and participate in the planning, preparation and review of periodic safety reports (e.g. DSUR, PSUR, PADER)

• Assist in assessment of medical safety data for assigned products, development and execution of safety signal and benefit-risk management strategies and closely collaborate with stakeholders.

• Participate in the presentation and analysis of safety data from on-going and completed clinical trials and from post-marketing sources.

• Prepare data for and actively participate in safety governance processes.

• As needed, review and provide safety input, for key study-related documents, e.g. protocols, Investigator’s Brochure (IB), or Informed Consent Form (ICF)

• Conducts quality review for signal detection and product safety scientist tasks which are low to high in complexity, or which concern low to high complexity products.

• Advises clients on safety related issues.

• Supports training and mentoring of junior colleagues.

• Contributes to development of processes, tools and systems.

• Ensures that tasks are conducted in accordance with company policies and procedures, contractual agreements, and applicable regulations.

• Participates in departmental initiatives; Serves as a subject matter expert in designated area.

• Responsible for routine project implementation and coordination for assigned projects, including leading kick-off meetings, coordination of communications and data requests, participation in client meetings, audits and inspections, and review of metrics and budgets.

• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.

• Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.

• Frequent contacts with internal personnel and outside customer representatives.

Qualifications:

• Bachelor’s or Master’s degree in pharmacy, nursing, healthcare or other life sciences fields.

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 10+ years).

• 10 + years Pharmacovigilance experience

• Extensive signal detection and safety risk management experience

• Expertise in pharmacovigilance requirements relating to marketed products and clinical trials across all major markets

• Extensive signal detection & management experience is a must.

• Understanding of the principles of databases, querying data sources as well as developing and applying search strategies

• Working knowledge of MedDRA

• Excellent attention to detail, data interpretation and medical-scientific writing skills

• Advanced critical thinking and problem-solving skills with ability to evaluate and escalate appropriately Solid project management skills with the ability to manage multiple projects simultaneously and ability to redress issues proactively with limited management intervention

• Ability to motivate, mentor and provide guidance to less experienced staff, routinely exhibiting robust and proactive scientific expertise

• Excellent oral and written English language communication skills, including paraphrasing skills

• Advanced computer skills with the ability to work within multiple systems; advanced skills in Microsoft Office products (including Outlook, Word, and Excel)

• Working knowledge of Oracle Empirica.

• Ability to maintain a positive and professional demeanor in challenging circumstances and to proactively plan for likely scenarios using personal experience

• Ability to work effectively within a team to attain a shared goal