Manager, Drug Safety - Ontario, Canada - Cencora

Cencora

Verified Company

Ontario, Canada

3 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

What you will be doing
PRIMARY DUTIES AND RESPONSIBILITIES:
Ensuring effectiveness of AE reporting processes, to meet and or exceed client expectations
Identifying needs for modification of program database, drug safety database, protocols and current processes
Leading and assisting team members assigned within the program to ensure effective results
Collaborate in identifying training requirement needs, leading refresher adverse event training as required in collaboration with Senior Manager, and Program Management
Participates in client consultations and working sessions usually in collaboration with the Senior Manager.
Responsible for daily and ongoing client reporting and project communications, including reporting of Adverse Events for assigned programs (as applicable)
Working with Senior Manager, and program management to ensure assigned program(s) is audit ready
Working with Quality Assurance and Senior Manager to perform regular Quality Checks for program AE reporting, including Source Document sampling
In the event of deviation from SOP, working with Senior Manager to oversee the CAPA process and activities
In collaboration with the Senior Manager, participates in the hiring and training process of new staff
Responsible for the recruitment, 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;
Ensures effective operations of team members under his/her responsibility,
Leads by example, to create strong team dynamics that result in successful, creative and innovative service offerings;
Demonstrates commitment to Innomar Strategies organization and inspires / mentors fellow employees;
Builds and maintains working relationships and networks that help to profile the company's services and capabilities and increase industry and build brand recognition through client communication, management and relationship building;
Maintaining up to date and relevant knowledge of Pharmacovigilance regulations including; GVP, ICH GCP MHRA, Canadian Food and Drugs Act, and US FDA guidelines
Perform case triaging, evaluation, including causality, severity and seriousness assessments as per client requirements and specific process
Literature searches as needed
Reconciliation of event reports
Submit ICSR cases to Regulatory Authorities and/or our clients, as applicable
Able to work any 8hour shift between 8:00 AM8 PM on a scheduled rotational basis
Rotational coverage of statutory holidays required
The Manager, Drug Safety will also be assigned other duties as required.
May be required to be on standby/on call as part of this role

EXPERIENCE AND EDUCATIONAL REQUIREMENTS:

Bilingual, English/French strongly preferred
Health Care Professional (Nurse, Pharmacist, MD) or Bachelor's degree in related discipline or diploma in a life sciences program
35 years' experience in Drug Safety, Clinical Research and/or equivalent and related experience in the pharmaceutical industry
Familiarity with Adobe Pro an asset
Can do attitude, with proven ability to meet strict deadlines
Knowledge of medical terminology is a strong asset
Able to work any 8hour shift between 8:00 AM8 PM, if necessary
Good internet required for remote work

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

Leadership and influential skills
Ability to deal with ambiguity
Strong knowledge of pharmacovigilance industry including up to date knowledge of; GUI 0102, GVP, ICH GCP MHRA, Canadian Food and Drugs Act, and US FDA guidelines an asset
Advanced knowledge of pharmaceutical distribution industry
Strong business and financial acumen
Strong analytical and mathematical skills
Ability to communicate effectively both orally and in writing
Effective interpersonal and leadership skills
Experience with people management is an asset
Effective organizational skills with attention to details
Ability to consistently meet deadlines
Excellent problemsolving skills; ability to resolve issues effectively and efficiently
Excellent presentation skills
Knowledge of Microsoft Word, Excel, PowerPoint and other Office Programs

What your background should look like

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 gro