Primary responsibilities :
- Medical review of Periodic Adverse Drug Experience Reports (PADERs) and periodic safety update reports (PSURs/ PBRERs) in compliance with drug safety regulations and ICH Guideline.
- Maintains current awareness of safety issues on Apotex products through ongoing monitoring & literature review demonstrating scientific skills in the research, analysis and interpretation of safety data.
- Prepares responses to slightly more complex queries, and requests for safety information from internal customer (RA, QA, NPD project teams etc).
Additional responsibilities:
- Develops and maintains SOPs.
- Develops and maintains training documents and tracks compliance of internal and external global partners involved in drug safety reporting.
- Maintains user-level knowledge of Oracle ARGUS and MedDRA terminology.
- Works as a member of a team to achieve all outcomes.
- Delivers all work in support of our Values of Collaboration, Courage, Perseverance and Passion; and all other duties as assigned.
- All other duties as assigned.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
Supporting responsibilities:
- May provide input and feedback to departmental process improvement strategy discussions.
- Contributes to the creation and promotion of an environment of teamwork ensuring excellence in customer service through the timely delivery of quality drug safety data.
- Liaises regularly and develops strong working relationship with external partners and international Apotex affiliates and demonstrates corporate values in the performance of work and in all interactions with others.
- Interacts with other internal departments when necessary.
- Contributes to interpretation of PV regulations and applies sound decisions related to regulatory guidelines and policies.
- Shows initiative to remain current on new PV regulations and international guidelines and seeks guidance from Group Leader and management to enhance knowledge.
- Performs all work in accordance with all established ICH guidelines, regulatory compliance and safety requirements and maintains current knowledge on all relevant Pharmacovigilance regulations.
- Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values - Collaboration, Courage, Perseverance and Passion.
- All other duties as assigned.
