Manager, Pharmacovigilance Special Consulting Services

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Job Details

Cencora Pharmalex is one of the leading service providers for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance. The success of our company resides in the expert knowledge and high motivation of our employees. Working for Pharmalex means being creative and adaptive. Our culture of continuous learning and commitment to diversity and inclusion creates an environment that allows you to build your skills and career.

The Manager of Pharmacovigilance Special Consulting Services is responsible for the execution of operational tasks and all aspects of technical delivery and

project management in the field of Pharmacovigilance. This is a remote based role that can be hired anywhere in the US.

Responsibilities :

• Case Management and project oversight
• Individual Case Safety Report (ICSR) assessment and triage of adverse drug reactions and product quality complaints deriving from literature clinical trials, solicited and spontaneous reporting systems;
• Expertise and knowledgeable regarding reporting requirements for FDA, EMA, MHRA and other competent authorities as applicable.
• Data entry quality control, including case assessment and reportability assessment.
• Oversight of team Pharmacovigilance activities including ICSR reporting, reconciliations, follow up requirements, literature screening, signaling, inquiry and complaint management.
• Communication with regulatory authorities and clients regarding all pharmacovigilance-focused aspects.
• Participation in the preparation, reviewing and approval of safety update reports PSURs (Periodic Safety Update Reports), PADERs (Periodic Adverse Drug Experience Reports) DSURs (Development Safety Update Reports), risk management plans and signal detection reports required and in support of risk-benefit profiling.
• Writing / Review of procedural documents such as Working Instructions, SOPs, Working Procedures, Templates etc. for PharmaLex PV projects.
• Program Management Support including budgeting and invoicing services
• Overview of needed resources for their projects, and communicating needs on an ad hoc basis.
• Review of Pharmacovigilance Intelligence Reports and perform gap analysis / impact assessment on own processes.
• Training of staff and maintaining documentation of trainings in all applicable selected areas of pharmacovigilance and client specific activities and requirements.
• Act as a mentor to project team members and colleagues or new in various projects / tasks.
• Proactive in suggesting improvements to the services offered to our clients in the SCS service line.
• US and International Travel required (approximately 10%)
• Client management and communication including ownership of regular and ad hoc client and team meetings including documentation and tracking of information discussed and convey to appropriate team members as applicable.
• Must have availability to work during US Eastern Standard Time (EST) business hours and also have flexibility for off business hours if needed.
• 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, qualifications and training, if required.

Education :

Experience :

Skills :

What Cencora offers

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 cencora

Full time

Salary Range

Equal Employment Opportunity

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 or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Affiliated Companies :

Affiliated Companies : PharmaLex US Corporation