Manager, Drug Safety

4 weeks ago

Oakville, Canada Cencora Full time

**Job Details**:
**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 on-going 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 8-hour shift between 8:00 AM-8 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
- 3-5 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 8-hour shift between 8:00 AM-8 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 problem-solving skills; ability to resolve issues effectively and efficiently
- Excellent presentation skills
- Knowledge of Microsoft Word, Excel, PowerPoint and other Office Programs

**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 tr

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