Benefits
- Commitment to work-life balance
- Disability insurance
- Floating leave days
- Insurance
- On-going training
- Paid leave
- Paid sick leave
- Performance bonuses
- Reimbursement for public transportation
New
Telecommuting
specialists in pharmacovigilance (Int.)
FOP Experts Conseils inc.
202-9420 Boulevard Taschereau, Brossard,QC- Salary To be discussed
-
37.50 to 40.0 h - Full time
-
Contract ,Permanent ,Telecommuting job
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Day shift work
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3 positions to fill as soon as possible
Description
POSITION DESCRIPTION
CANDIDATE PROFILE
WORK MODE
WHAT WE OFFER
Read more
FOP CONSULTANTS is looking for specialists in pharmacovigilance at the intermediate level motivated to deliver on mandates for its clients in the pharmaceutical and biopharmaceutical sector. The mandate is to process and assess adverse event reports, submit reports to the authorities and detect safety signals and to contribute to periodic reports and risk management plans in compliance with GVP and Health Canada requirements.
KEY RESPONSIBILITIES- Receive, assess and enter adverse event reports.
- Code cases (MedDRA) and assess their causality and seriousness.
- Submit expedited reports to the authorities within the required timelines.
- Perform signal detection and contribute to periodic reports (PSUR/PBRER).
- Contribute to risk management plans and risk minimization measures.
- Maintain procedures, the safety database and compliance with GVP.
- Collaborate with medical affairs, regulatory affairs and partners.
CANDIDATE PROFILE
- Bachelor's or master's degree in science (pharmacology, pharmacy, chemistry, biochemistry, biology, pharmaceuticals, drug development, etc.), or any other related discipline;1 (one) to 10 (ten) years of industry experience, preferably in the (bio)pharmaceutical sector.
- Five (05) to ten (10) years of industry experience.
- Three (03) to seven (07) years of experience as a Specialist in Pharmacovigilance.
- Sector standards: GMP (Health Canada), FDA 21 CFR 210-211, ICH Q7 to Q10, GAMP 5, ISO 9001.
- Tools and systems: MS Office suite, Argus Safety, ArisGlobal, MedDRA, EudraVigilance.
- Hold one of the following certifications: Pharmacovigilance training, GCP (ICH E6), MedDRA.
- The following are considered assets: RAC (RAPS), epidemiology certification.
- Experience in Canadian public or private organizations.
- Language: French and English
WORK MODE
- Remote, Hybrid, On-site
WHAT WE OFFER
At FOP CONSULTANTS, we invest in the success and well-being of our experts. By joining our team, you benefit from an environment designed to support your performance and respect your work-life balance, including:
- Competitive compensation that reflects your expertise;
- Complete protection through our group insurance plans;
- Professional liability insurance so you can practise with confidence;
- Remote-work flexibility, based on client needs;
- 3 weeks of vacation to recharge;
- 3 paid sick days, to take care of yourself;
- A monthly allowance for your transportation costs;
- Real opportunities for advancement within the organization;
- Ongoing access to training to grow your skills.
Work environment
Equal Opportunity Employer
This employer is an equal opportunity employer committed to diversity and inclusion. We are pleased to consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veterans status, Aboriginal/Native American status or any other legally-protected factors. Disability-related accommodations are available on request for candidates taking part in all aspects of the selection process.
Requirements
Level of education
University
Diploma
BAC
Completed
Work experience (years)
3-5 years
Written languages
Fr : Advanced
En : Intermediate
Spoken languages
Fr : Advanced
En : Intermediate
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