Special Consulting Services Specialist - Pharmacovigilance, Epidemiology & Risk Management

Assist with the Pharmacovigilance, Epidemiology & Risk Management operational tasks and all aspects of technical delivery and project management.

Responsibilities

• Pharmacovigilance Team Support

• Data entry and QC of Individual Case Safety Reports (ICSR) of adverse drug reactions deriving from clinical trials, spontaneous reporting systems and the literature; reporting of ICSRs to the competent authorities

• Support in the generation, processing, documenting, and tracking of follow-up requests

• Perform L2A and MLM for relevant clients

• Screening and documentation of scientific global and local literature regarding safety relevant publications

• Follow up calls to patients or health care professionals and documentation of calls within trackers or the safety database

• Monitoring of incoming email for multiple programs

• Regulatory submissions of Individual Case Safety Reports and /or to partners

• Perform reconciliation with clients and applicable partners

• Complete monthly/quarterly metrics and KPIs in excel spreadsheets

• Support the Program Manager or Workstream Lead with all necessary information related to the specific project/program, as needed.

• PSMF maintenance

• Participate and help prepare for audits or inspection

• Prepare deviations concerning SCS practice area

• Assist with administrative tasks in the creation of periodic reports PSURs (Periodic Safety Update Reports), DSURs (Development Safety Update Reports), PADERs (Periodic Adverse Drug Experience Reports), risk management plans and signal detection reports

• The employee agrees to take over primary listed tasks and responsibilities in other service lines, project management activities as client contact point and additional reasonable tasks that align with their abilities, qualification and training, if required.

Education and Work Experience

• Professional education or University degree in Life Science

• Basic understanding/knowledge in the field of pharmacovigilance

Skills and Knowledge

• Ability to prioritize and manage own time and tasks.

• Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as client's team lead level.

• Good communication skills (written and verbally); capability to point out issues and provide potential options for solution in the area of expertise.

• English business fluent & local language (as appropriate).

We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members' ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more. For details, visit https://www.virtualfairhub.com/cencora

*This Salary Range reflects a National Average for this job. The actual range may vary based on your locale. Ranges in Colorado/California/Washington/New York/Hawaii/Vermont/Minnesota/Massachusetts/Illinois State-specific locations may be up to 10% lower than the minimum salary range, and 12% higher than the maximum salary range.

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

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