ADVANZ PHARMA has an exciting opportunity for a Drug Safety Scientist role to join our Mumbai based team.
*Please note:- Physician with Medical Writing experience (e.g. PSURs, Safety variations, RMPs, Clinical and Non-Clinical components of product dossiers) and PV Audit Experience
· Main purpose of role:
- The role of the Medical Office is to bring medical/scientific and drug safety related insights and expertise to ADVANZ PHARMA and to be subject matter experts across the following functional areas: medical affairs, medical compliance, patient safety, clinical development and post marketing research and medical operations. This entails engaging and collaborating with healthcare organizations, healthcare professionals and customers – both internal and external – and generating and communicating relevant, meaningful and impactful data. In so-doing, the Medical Office: represents the voice of the patient in all matters; works to ensure that products are supported by relevant, up to date data and retain a positive benefit/risk profile; helps to drive our scientific credibility and reputation as a company; enables stakeholders to make informed choices for patients; operates with due regard to all relevant regulations and compliance requirements.
- Well versed with most updated PV Guidelines and all aspects of aggregate reports, signal detection and Risk management plans.
- Play an active role within the Drug Safety Team, accountable for monitoring and managing all aspects of product and patient safety in line with local and global pharmacovigilance requirements including GPvP
- Support the Drug Safety team in the maintenance of product safety profiles and provide clinical expertise and rationale to defend existing product portfolio.
- Identify and execute strategies in PV to ensure real time compliance
Key responsibilities (In Points):
• Draft/Review of Periodic Safety Update Reports and Periodic Adverse Drug Experience Reports from a medical standpoint
• To prepare Signal reports (including DSR, DEP, SAR as applicable) and managing the compliance and quality of signal detection.
• Medical writing to support product safety reviews and clinical evaluations
• Support if required to draft/review ad hoc safety reports like RMP, CES, HA response in stipulated time frame.
• Contribute towards continued improvement of safety systems and processes
• Oversight of safety related variations and maintenance of product information
• Keep abreast of changing PV requirements across Europe and Rest of World
• Represent the company during Scientific meetings and Audits and Inspections
• Compliance with GPvP requirements, demonstrated through audits and inspections.
• Support to the business and provision of documentation within agreed timeframes.
• Successful relationships with all external partners.
• Address internal and external inspection findings.
• Ensure all documentation is structured and maintained as required
• Ensure PV systems are in line with industry standards.
• Interaction with Regulators, patients and prescribers from a safety perspective if required.
Apply through this Link