What is the role of a pharmaceutical researcher?
A pharmaceutical researcher or pharmaceutical scientist contributes to expanding medical knowledge and drug development through clinical research. Their primary responsibility is to conduct and oversee various pharmaceutical research projects to ensure their successful execution and compliance with regulations. Pharmaceutical researchers are part of a team that includes other researchers, physicians, data analysts, and other stakeholders, working together to ensure the effective and ethical conduct of clinical trials and research studies.
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Pharmacovigilance Specialist
Branche: Pharmaceuticals
Expertise: Production & Manufacturing
Experience: 2 years
Responsibilities Collaborate in maintaining an efficient vigilance system in compliance with the Health Canada regulations and guidelines, participating in other Pharmacovigilance (PV) processes and ensuring appropriate contacts with internal and external stakeholders. Collect, pursue follow-up information to complete quality adverse event reports and transmit all local adverse events to Global Pharmacovigilance (GPV). Document and update case information into the PV safety database as as per Good Documentation Practices (GDPs). Analyze and process adverse events and safety reports with utmost quality and timeliness in accordance with Global and Local PV procedures. Respond to queries and requests from internal and external stakeholders. Evaluate domestic and foreign ICSRs (marketed and non-marketed drugs) for submission to Health Canada according to Canadian regulations and within prescribed timelines. Collaborate in developing and maintaining the local Pharmacovigilance standard operating procedures (SOPs), work instructions and job aids. Provide support in the Periodic Safety Report activities in accordance with Canadian regulations and corporate procedures. Support activities involving product launch, risk management plans, studies, safety queries, handling product alerts, and review of product monographs and protocols. Provide support in the maintenance of Canadian product list and reporting rules for PV database configuration. Support local literature review activities including oversight of the review performed by global vendors, maintaining lists of journals and products, and handling literature-related queries. Provide training and on-going support as well as perform quality assurance and quality control for work delegated to the global PV vendors (CPOC, i.e. Country PV Operating Center) and addressing issues. Provide support for Signal Detection and Local Safety Surveillance activities in accordance with regulatory and corporate requirements. Maintain current knowledge of all relevant local Pharmacovigilance regulations for Sanofi marketed products. Educate internal and external stakeholders on the implications of existing PV regulations and guidance documents along with local and global procedures and policies. Provide support in monitoring compliance with Canadian and foreign case management activities and implement corrective and preventative actions involving the PV team. Participate in the ongoing optimization of PV procedures as well as inter-departmental procedures affecting PV. Provide overall support to the PV team activities.
Patient Support Program Manager
Location: Toronto
Branche: Pharmaceuticals
Expertise: Communications & Distribution
Experience: 3 years
Responsibilities Work with brand teams to identify patients' needs, understand customers' expectations and ensure competitive landscape assessment. Co-development of our overarching PSP strategy based on the needs/expectations of our customers and aligned with global design principles, the brand team guidance and local brand team leadership. Bring expertise in requirements that are specific to PSP design & implementation in Canada and to our Business Units Co-lead the cross functional team (brand, medical, IT, patient safety, quality, supply chain, legal, ethics & compliance, market access, government affairs, finance, etc.) to design all details/offerings of the program and ensure governance approval. Collaborate with the cross-functional team to define capabilities and required resources for a successful launch. Champion quality in the delivery of existing PSPs to continuously improve and streamline our existing PSP. Act as conduit between Lilly and PSP vendor managing the interactions with patients to ensure timely issues resolutions. Collaborate with our PSP vendors to and ensure we are delivering on the customer experience, that we are continually adjusting to the dynamics of the market and that we adopt an innovative mindset. Conduct regular meetings and Cross Functional Quarterly Business Unit Review to ensure adherence to our Key Performance Indicators (KPI) and efficiency in the delivery of our programs. Conduct regular call monitoring and review of customer surveys and share proactively with cross functional brand. Work proactively with the cross functional brand team to review customer feedback & leverage environment insights to ensure our programs continue to be a valuable resource to our patients and HCP. Ensure PSP is run in accordance with Lilly Standards (Patient Safety, Medical Quality, Customer Experience principals, etc.) and that relevant training is provided as needed. Lead the budgeting, financial tracking to ensure adherence to contracts with our vendors. Be part of the PSP team, working collaboratively with PSP owners and sharing learnings to enhance the overall PSP capabilities at Lilly Canada and ensure we deliver best in class PSPs across all of our brands. Participate regularly with the PSP working sessions, formal PSP Governance reviews, and full PSP quarterly review to ensure the PSP team is delivering on the high standards that we have committed to.
Medical Information Associate
Location: Canada
Branche: Pharmaceuticals
Expertise: Communications & Distribution
Experience: 2 years
Responsibilities Handle escalated (2nd-line) medical information inquiries from the outsourced Medical Information Contact Centre (MICC) during Canadian business hours (approx. 4 hours/day, Monday to Friday). Respond to urgent inquiries after business hours, if necessary, in collaboration with local medical affairs. Ensure responses are accurate, timely, and compliant with regulations and company SOPs. Coordinate the creation, review, and maintenance of Canadian-specific technical and medical response documents, including: Scientific response documents (LSRDs) FAQs, Q&As, medical letters, and technical sheets Ensure alignment with global content and Canadian regulations. Collaborate with MICC vendor and cross-functional teams (Medical, Regulatory, CMC, Legal, Communications) to ensure up-to-date and appropriate content is available. Analyze customer inquiry trends and share insights with Commercial, Innovation, and Medical teams to better address customer needs. Present quarterly summaries at the CHC (Consumer Healthcare) monthly team meeting. Deliver training sessions on Medical Information processes to internal teams (e.g., commercial and field) and MICC agents, particularly for new products. Support the analysis and response to product discontinuations, crisis situations, or inquiries from Health Canada and other external stakeholders. Provide inquiry metrics to Pharmacovigilance (PV) and/or Quality Assurance (QA) teams to support AE-PTC reconciliation reporting. Contribute to audit and inspection readiness, including Opella Global Quality Audits (GQA) and Health Canada inspections. Conduct quality checks on MICC responses to ensure scientific accuracy and compliance, identify trends, and implement Corrective and Preventive Actions (CAPAs) as needed. Maintain strong relationships with both Canadian and Global Medical Information teams to foster alignment and optimize knowledge sharing. Coordinate after-hours coverage and support logistics with MICC service providers.
What do pharmaceutical researchers do?
In this role, pharmaceutical researchers perform several essential tasks to facilitate successful pharmaceutical science. They collaborate with medical professionals, principal investigators, and other team members to define research objectives and design appropriate research protocols. Additionally, they work closely with regulatory authorities to obtain necessary approvals and ensure compliance with all relevant laws and guidelines governing pharmaceutical research.
They are responsible for recruiting and enrolling study participants, making sure that the appropriate target population is included. Maintaining accurate and organized records, managing data collection and analysis, and addressing any data-related issues that may arise during the study are also part of their responsibilities.
Moreover, pharmaceutical scientists need to lead the monitoring and auditing of research sites to ensure data quality, accuracy, and adherence to good clinical practice (GCP) standards. Implementing safety measures and conducting risk assessments are vital to ensuring patient safety throughout the research process.
Staying updated with the latest advancements in pharmaceutical research methodologies, technologies, and regulatory requirements is essential. By integrating cutting-edge practices, they can optimize innovation and success of research projects in the pharmaceutical field.
What are the required skills for a pharmaceutical researcher?
pharmaceutical researchers need a variety of skills. Strong leadership and project management abilities are essential for effectively coordinating and motivating teams throughout the research process. Excellent communication skills are also necessary for facilitating collaboration between team members, investigators, and other sector stakeholders. They should be able to communicate complex scientific information clearly and concisely.
In addition, in-depth knowledge of pharmaceutical research regulations, including GCP, and familiarity with the drug development process are vital for ensuring compliance and successful execution of studies. Analytical and problem-solving skills are also crucial for handling challenges and making informed decisions during the research process.
Where do pharmaceutical researchers work?
Pharmaceutical researchers can find job opportunities in various settings, including pharmaceutical companies, contract research organizations (CROs), academic institutions, hospitals, and government agencies. They may also work in specialized research facilities or medical device companies conducting clinical trials for new drugs and treatments.
Common pharmaceutical researcher responsibilities
Conduct and oversee pharmaceutical research projects, coordinating interdisciplinary teams;
Develop and implement research protocols, ensuring compliance with regulations and ethical guidelines;
Work closely with investigators and stakeholders to define research objectives and expectations;
Oversee participant recruitment and enrollment, ensuring the inclusion of the appropriate target population;
Maintain accurate and organized records of research progress, data collection, and analysis;
Perform data quality checks and address data-related issues as they arise;
Ensure patient safety by implementing safety measures and conducting risk assessments;
Monitor and audit research sites to ensure adherence to GCP standards;
Stay informed about the latest advancements in pharmaceutical research methodologies and regulatory requirements;
Communicate effectively with team members, investigators, and stakeholders to facilitate collaboration and project success;
Provide guidance and support to researchers and study coordinators throughout the research process.
Qualifications for pharmaceutical researchers
To become a pharmaceutical researcher, candidates should possess at least a Bachelor's degree in a relevant field, such as pharmaceutical sciences, life sciences, biomedical sciences, or healthcare management. Advanced degrees or certifications in pharmaceutical research or a related discipline are advantageous.
Other essential qualifications include:
- 2-4+ years of experience in pharmaceutical research or related healthcare projects;
- In-depth knowledge of pharmaceutical research regulations, including GCP;
- Strong project management and leadership skills;
- Excellent verbal and written communication abilities;
- Analytical and problem-solving skills;
- Familiarity with the drug development process and research methodologies;
- Ability to work collaboratively with interdisciplinary teams;
- A commitment to ensuring patient safety and contributing to advancements in healthcare through pharmaceutical research.
