Manager, Pharmacovigilance and Medical Information
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!
What you will be doing
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.
What your background should look like
EXPERIENCE AND EDUCATIONAL 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
MINIMUM SKILLS, KNOWLEDGE, AND ABILITY REQUIREMENTS:
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.
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 https://www.virtualfairhub.com/amerisourcebergen
Affiliated Companies:Affiliated Companies: Innomar Strategies
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.
COVID-19 Vaccine Policy
As of October 18, 2021, Cencora requires all Canadian team members to be fully vaccinated and show proof of completed vaccine status at time of hire. If you cannot receive the COVID-19 vaccine due to a qualifying medical condition or sincerely held religious belief you will be required to follow AmerisourceBergen’s policy and process to apply for an exemption/accommodation.
AmerisourceBergen is committed to fair and accessible employment practices. When requested, AmerisourceBergen will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment.