- Pharmacovigilance & Drug Information Officer
- Pharmacovigilance & Drug Safety
- Pharmacovigilance & Medical Information
- Pharmacist by training (PharmD)
- M.Sc. in Health Sciences
- Medical professionals (Nurses and Foreign trained MDs)
- B.Sc. in health sciences with some experience
- Look up the following titles as well: medical affairs officer, medical information officer, medical information scientist
- There are 2 core responsibilities
- Medical Information
- Ensures the company is compliant with Global Regulatory and Health Canada for adverse drug reaction reporting.
- This is done by assessing the adverse drug reports and monitoring it for any potential risks. If any potential risk is identified, action is taken within the specified time frame.
- Scanning the scientific literature, any media, adverse drug reactions reported by the customers and Health Canada’s adverse reaction data base for product related adverse reaction.
- Assess to determine if there are any issue that needs to be managed such if the risk is more than the benefit.
- Participate in the Health Canada audit regarding whether the company is compliant with Health Canada for adverse drug reaction reporting.
- Write Periodic Benefit-Risk Evaluation Report (PBRER), Annual summary Safety Reports (ASR) and/ or Risk Management Plans. Risk management plans involve assessing what the risks are and how to monitor them.
- Characterize each reported symptoms into the medical term category as per MEDDRA (medical drug dictionary) and characterize the case into serious and non-serious.
- Assessment of a serious case for Canadian market is done by following the guidelines set by Health Canada and ICH guidelines. This will be followed by creating reports on database and sharing it with the company affiliate and assessing if it needs to be reported to Health Canada.
- If the pharmacovigilance officer identifies an adverse reaction as a serious case, they will make recommendation to the company to have the product recalled
Medical Information Responsibilities
- Responsible for developing Core Company Safety Information (CCSI) section of Core Company Data Sheet (CCDS). This serves as a base for product monograph.
- Customer service
- Respond to questions about the drugs from customers, medical professionals and anyone.
- Be able to handle difficult phone calls from emotionally charged customers empathically and in a professional manner
- When bringing a new product to the market, generate standard response letter with answers to frequently asked questions. Throughout the product life cycle, update the standard response letters to reflect additional questions that were received.
- Provide product monograph training to sales reps.
Must Have Skill Sets
- Excellent Communication, Interpersonal Skills, Writing Skills
- Attention to details
- Able to answer questions by customers
- provide fact based and scientific answers only
- handle emotionally driven phone calls
- answer tough questions
- Ability to write scientific letters
- Good at literature search and be able to analyze and critically appraise a literature article
- Microsoft Office
- Helps to be able to speak/ understand the country’s official languages (Canad –> English & French)
Type of Companies with this role
- Medical Device Companies
- Regulatory agencies
Associate –> Senior –> Manager –> Director/ VP