Manager, Pharmacovigilance and Medical Information

Cencora

About The Position

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today! Job Details PRIMARY DUTIES AND RESPONSIBILITIES: Act as the primary point of contact for Innomar clients while overseeing all pharmacovigilance and Medical Information call center activities. Organize, manage, and maintain a highly compliant Pharmacovigilance (PV) system and medical information call center for Innomar clients. Act as Pharmacovigilance expert and support team for pharmacovigilance operational activities; Ensure compliance with respect to pharmacovigilance operational activities as per Health Authorities’ requirements and Client agreements. Provides support with the handling of medical inquiries; Acts as the scientific expert and as the escalation point for triage of medical inquiries from the medical information call center; Works with Patient Support Program Managers, 3PL team members, and Quality Assurance and IT teams to ensure program compliance with respect to client expectations and as required by Health Authorities’ requirements. Ensures development and updating of Standard Operating Procedures (SOPs) and Work Instructions (Wl) for respective programs. Ensures completion and maintenance of training documents and all required reference documentation (product monographs, disease state descriptions, SOPs, etc.). Monitors quality control practices, documents and identifies any trending errors/concerns and provides resolution; Responsible for the recruitment, on-boarding / off-boarding, training, coaching, and performance management of team members, creating and promoting an environment of teamwork, empowerment, and engagement; Trains, motivates, and retains an efficient, knowledgeable, and effective staff; Identifies training needs based on monitoring, and leads refresher training as required and determined as necessary, Works with HR and the training department to bring training opportunities to the team as deemed relevant; Ensures effective operations of all team members, Leads by example, to create strong team dynamics that result in successful, creative, and innovative service offerings; Demonstrates commitment to the organization and inspires / mentors fellow employees. Builds and maintains working relationships and networks that help to profile the company services and capabilities and increase industry and build brand recognition through client communication, management, and relationship building; Monitors daily and ongoing client reporting and project communications for completion, accuracy, and timeliness; Works with relevant groups (IT, QA) to identify needs for set up, and modification of pharmacovigilance database, protocols, and workflows; Identifies process improvements and leads and participates in database upgrades and testing initiatives. Participates in client consultations and working sessions in collaboration with the Director of Pharmacovigilance, and provides input on proposals, including reviewing PV agreements, SDEAs, and SOWs; Lead and coordinate internal and external PV audits and inspections. ; Ensures that corporate policies are followed and that reviews and audits of processes are implemented and documented according to company policy; Works with the Director of pharmacovigilance to ensure fiscal responsibilities are met; Identifies areas for process improvements, evaluates for potential, and oversees implementation; Ensures high-quality deliverables (internal and external) are completed on time. Responsible for daily and ongoing client reporting and project communications Able to work any 8-hour shift between 8:00 AM-8 PM on a scheduled rotational basis; On-call availability for rotational statutory holiday coverage where required. The Manager Pharmacovigilance and Medical Information will also be assigned other duties as required.

Requirements

Bilingual, English/French strongly preferred.
Bachelor’s degree in a related Health Care field (Pharmacy, Dental, Pharmacology, Nursing, or Medical Degree)
5 years of experience in the Pharmacovigilance or Medical information area of the pharmaceutical industry
Advanced knowledge of the pharmacovigilance industry including up-to-date knowledge of Health Canada, US-FDA, EMA, MHRA, and ICH’s Pharmacovigilance requirements and guidelines
Strong expertise with MS Word, MS Excel, MS PowerPoint, other MS Office Programs, and Adobe Pro
Excellent presentation skills, analytical and mathematical skills
Excellent Leadership and influential skills with people management experience
Ability to deal with ambiguity and consistently meet deadlines.
Strong business and financial acumen
Ability to communicate effectively both orally and in writing.
Effective organizational skills with attention to details
Excellent problem-solving skills and; ability to resolve issues effectively and efficiently.

Responsibilities

Act as the primary point of contact for Innomar clients while overseeing all pharmacovigilance and Medical Information call center activities.
Organize, manage, and maintain a highly compliant Pharmacovigilance (PV) system and medical information call center for Innomar clients.
Act as Pharmacovigilance expert and support team for pharmacovigilance operational activities
Ensure compliance with respect to pharmacovigilance operational activities as per Health Authorities’ requirements and Client agreements.
Provides support with the handling of medical inquiries
Acts as the scientific expert and as the escalation point for triage of medical inquiries from the medical information call center
Works with Patient Support Program Managers, 3PL team members, and Quality Assurance and IT teams to ensure program compliance with respect to client expectations and as required by Health Authorities’ requirements.
Ensures development and updating of Standard Operating Procedures (SOPs) and Work Instructions (Wl) for respective programs.
Ensures completion and maintenance of training documents and all required reference documentation (product monographs, disease state descriptions, SOPs, etc.).
Monitors quality control practices, documents and identifies any trending errors/concerns and provides resolution
Responsible for the recruitment, on-boarding / off-boarding, training, coaching, and performance management of team members, creating and promoting an environment of teamwork, empowerment, and engagement
Trains, motivates, and retains an efficient, knowledgeable, and effective staff
Identifies training needs based on monitoring, and leads refresher training as required and determined as necessary, Works with HR and the training department to bring training opportunities to the team as deemed relevant
Ensures effective operations of all team members, Leads by example, to create strong team dynamics that result in successful, creative, and innovative service offerings
Demonstrates commitment to the organization and inspires / mentors fellow employees.
Builds and maintains working relationships and networks that help to profile the company services and capabilities and increase industry and build brand recognition through client communication, management, and relationship building
Monitors daily and ongoing client reporting and project communications for completion, accuracy, and timeliness
Works with relevant groups (IT, QA) to identify needs for set up, and modification of pharmacovigilance database, protocols, and workflows
Identifies process improvements and leads and participates in database upgrades and testing initiatives.
Participates in client consultations and working sessions in collaboration with the Director of Pharmacovigilance, and provides input on proposals, including reviewing PV agreements, SDEAs, and SOWs
Lead and coordinate internal and external PV audits and inspections.
Ensures that corporate policies are followed and that reviews and audits of processes are implemented and documented according to company policy
Works with the Director of pharmacovigilance to ensure fiscal responsibilities are met
Identifies areas for process improvements, evaluates for potential, and oversees implementation
Ensures high-quality deliverables (internal and external) are completed on time.
Responsible for daily and ongoing client reporting and project communications
Able to work any 8-hour shift between 8:00 AM-8 PM on a scheduled rotational basis
On-call availability for rotational statutory holiday coverage where required.
The Manager Pharmacovigilance and Medical Information will also be assigned other duties as required.

Benefits

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.

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