Job Summary
Prepares periodic safety update reports (PSURs/ PBRERs) in compliance with drug safety regulations and ICH Guideline. Utilizes best medical judgement in the analysis and evaluation of adverse reports, promptly resolving causality assessment queries and any other impreciseness in reporting by actively liaising with the reporting sites. Participates in global new product development (NPD) project teams and supports Product Life Cycle Management (PLCM) activities.
Job Responsibilities
Primary responsibilities
- Prepares periodic safety update reports (PSURs/PBRERs/PADERs) for regulatory submission.
- 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.).
- 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.
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.
- All other duties as assigned.
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.
Job Requirements
- Education
- Physicians, Pharm.D, M Pharm, Nursing or related Health Science discipline
- Knowledge, Skills and Abilities
- Excellent analytical and problem-solving skills
- Excellent oral/written communication in English.
- Knowledge of MedDRA, Oracle ARGUS & online literature searching preferred
- Excellent organizational & interpersonal skills; experience in working in a dynamic team environment
- Excellent knowledge of relevant local and international regulations and ICH guidelines on safety data management in clinical trials and post-approval
- Advanced knowledge of Microsoft Office: Excel, PowerPoint, Word
Experience
- Core PV experience of at least 2-3 years’ pharmaceutical experience
- Periodic safety and risk management scientist: Preferred experience of at least 1-2 years on periodic reviews on aggregate safety data
- Location: Mumbai, MH, IN, 400083
- Job ID: 579377917