Job title: Pharmacovigilance Executive – PV PSRM
Location: Mumbai, MH, IN
Employment type: Full-time
Job Summary
As a Pharmacovigilance Executive in PV PSRM, you will prepare periodic safety update reports (PSURs/PBRERs) following drug safety regulations and ICH guidelines. You will analyze and evaluate adverse reports using your medical judgment, resolving any reporting issues quickly. You will also support new product development (NPD) teams and Product Life Cycle Management (PLCM) activities.
Job Responsibilities– Pharmacovigilance Executive!
Primary Responsibilities:
- Prepare periodic safety update reports (PSURs/PBRERs/PADERs) for regulatory submission.
- Stay updated on safety issues of Apotex products through monitoring and literature review.
- Respond to complex safety queries from internal customers (RA, QA, NPD project teams).
- Adhere to all compliance programs, including the Global Business Ethics and Compliance Program, Global Quality policies, Safety and Environment policies, and HR policies.
Additional Responsibilities:
- Develop and maintain Standard Operating Procedures (SOPs).
- Create and update training documents and track compliance of global partners in drug safety reporting.
- Maintain user-level knowledge of Oracle ARGUS and MedDRA terminology.
- Collaborate with team members to achieve outcomes.
- Deliver work supporting our values of Collaboration, Courage, Perseverance, and Passion.
- Perform other duties as assigned.
Supporting Responsibilities:
- Provide input and feedback on departmental process improvement.
- Promote a team environment to ensure excellence in customer service with timely delivery of quality drug safety data.
- Develop strong working relationships with external partners and international Apotex affiliates.
- Interact with other internal departments as needed.
- Interpret PV regulations and make sound decisions related to regulatory guidelines and policies.
- Stay current on new PV regulations and international guidelines.
- Perform all work following ICH guidelines, regulatory compliance, and safety requirements.
Job Requirements
Education:
- Physicians, Pharm.D, M Pharm, Nursing, or related Health Science discipline.
Knowledge, Skills, and Abilities:
- Excellent analytical and problem-solving skills.
- Strong oral and written communication in English.
- Knowledge of MedDRA, Oracle ARGUS, and online literature searching is preferred.
- Excellent organizational and interpersonal skills; experience working in a dynamic team environment.
- Strong knowledge of relevant local and international regulations and ICH guidelines on safety data management.
- Advanced skills in Microsoft Office: Excel, PowerPoint, Word.
Experience:
- Core PV experience of at least 2-3 years in the pharmaceutical industry.
- Preferred 1-2 years of experience in periodic reviews on aggregate safety data.
About Apotex Inc.
Apotex Inc. is a Canadian pharmaceutical corporation founded in 1974 by Barry Sherman. It is the largest producer of generic drugs in Canada, with annual sales exceeding CA$2.5 billion. By 2023, Apotex employed close to 8,000 people, making it Canada’s largest drug manufacturer. The company offers over 300 products sold in more than 115 countries. Apotex manufactures and distributes generic medications for various diseases and health conditions, including cancer, diabetes, high cholesterol, glaucoma, infections, and blood pressure.
Apotex is a member of several industry associations, including the Canadian Generic Pharmaceutical Association (CGPA), the Generic Pharmaceutical Association (GPhA), the Canadian Animal Health Institute (CAHI), the Canadian Association for Pharmacy Distribution Management (CAPDM), and Greater Toronto Area’s Partners in Project Green.
For more information, visit: www.apotex.com.
At Apotex, we are committed to creating an inclusive, accessible work environment where all employees feel valued, respected, and supported. We offer accommodations for applicants with disabilities as part of our recruitment process. If you are contacted for an interview or testing, please let us know if you require accommodation.
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