Janssen Pharmaceutical, a company of Johnson & Johnson is hiring a Director Drug Safety & Surveillance located at our head office in Toronto, ON.
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, metabolic and chronic diseases. Driven by our commitment to patients, we bring innovative products, services and solutions to people throughout the world. Janssen Inc. is a member of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit www.janssen.ca for more information.
Lead a team of drug safety specialists to ensure global compliance in safety reporting, case processing and product risk management strategy development for marketed and pipeline products. Establish strong alignment with Global Safety team to achieve high global standard by driving advance technology development locally. Contribute strategically to other business functions in terms of medical and compliance advice to ensure Janssen Canada meets all corporate and Health Canada requirements.
- Ensures safety reporting complies with all Health Canada regulations.
- Identifies resource needs and allocations to ensure appropriate functioning of the department.
- Leads internal Pharmacovigilance audits and Health Authority Pharmacovigilance Inspections and ensures Audit readiness of the Local Operating Company from a Pharmacovigilance perspective.
- Implements innovative solutions to ensure efficiency and works with managers to develop unified, consistent processes that meet regulatory standards and ensure regulatory compliance.
- Oversees staff development planning (goals and objectives) and the execution of those plans. This would include delegation and mentoring of managers.
- Guides and directs managers in the evaluation of staff training needs. Ensures that all staff members are trained in SOP's, guidelines and data standards to ensure compliance with local and/or global regulations and corporate policies.
- Participates in local and international multidisciplinary functional teams.
- Liaises with regulatory affairs, quality management and clinical groups in the management of safety issues relating to investigational and post-market compounds.
- Creates and implements the strategic direction for safety within the local operating company ensuring alignment with the global and local strategy.
- Responsible for local Pharmacovigilance contracting and oversight of Pharmacovigilance agreements.
- Performs other related duties as required (e.g. due diligence activities, SOP review).
- A minimum of a PharmD or Doctor of Medicine is required(i.e. MD, MBBS and BMBS).
- Extensive knowledge and experience with clinical study and spontaneous safety reporting, and regulatory compliance usually exhibited by a minimum 8 years in pharmaceutical safety related areas.
- A minimum of 5 years of direct people management experience is required.
- Canadian clinical experience is preferred.
- Ability to evaluate operations and procedures against outcomes and identify methods for improving efficiency, accuracy and compliance.
- Leadership skills for planning professional development of direct reports.
- Strong administrative and supervisory skills with substantial experience in pharmaceutical safety areas.
- Ability to allocate resources and provide personnel supervision and management.
- Ability to coordinate and harmonize the workflow activities across Drug Safety and Surveillance department.
- Ability to identify training needs of the staff within the Drug Safety and Surveillance department.
- Ability to facilitate change.
- Experience with international safety reporting.
- Experience with multinational/multi-company integration activities.
- Knowledge or experience with Excel, PowerPoint and Visio.
- This position may require up to 20% of domestic and international travel.
Janssen Inc. (7710)
Drug & Product Safety Operations
Click here for more info: https://jnjc.taleo.net/careersection/2/jobdetail.ftl?job=8612170817&lang=en
• Post ID: 83968648 toronto