Manager, Pharmacovigilance and Medical Information

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 pharmacovigilanceoperational 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 Assuranceand 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 andleads 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 ManagerPharmacovigilance and Medical Information will also be assigned other duties as required.

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)

5years of experiencein 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 expertisewith 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 skillsand; ability to resolve issues effectively and efficiently.