Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required.
Develop and implement quality and compliance metrics for new safety case management and aggregate reporting processes, working with the process/metrics owners, Quality Assurance (QA) and other global line functions as appropriate.
Lead projects to optimize methodologies and processes used to monitor safety cases and aggregate reports quality as well as internal and regulatory compliance.
Act as Signal Management responsible person on post-marketing and clinical trial projects. Author and/or QC review all types of signal management deliverables. Responsible for full documentation and tracking of signals.
Participate in internal and external audits and inspections, as required.
Develop and maintain tools in collaboration with Innovation, Tech & Systems and other Global Line Functions to assist in the monitoring of quality and compliance, introducing automation where possible.
Maintain procedural documents including manuals. Develop and implement training material and communications Assess the impact of any changes to worldwide regulations and update as required in order to ensure continued suitability.
Lead investigations in to any deficiencies identified, develop and implement corrective and preventative actions (CAPAs) and measuring the effectiveness of these.
Act as a subject matter expert during audits and inspections (e.g. CDSCO, FDA and EMA), lead the preparation of responses to findings and the development and implementation of CAPAs.
Collaborate with other Global Line Functions across Akums Divisions, including Patient Safety Alliance, medical affairs and marketing to ensure implementation of CAPAs and fulfilment of the safety requirements.
Ensure Good Documentation Practices (GDP).
In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents.
Required Candidate profile
M. Pharm, PharmD, MSc degree in life sciences or equivalent. Fluency in English.
Minimum 4 to 6 years of experience in the pharmaceutical industry, particularly in Pharmacovigilance.
In depth knowledge and understanding of applicable global, regional, local regulatory requirements i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs.
Strong negotiation, presentation and communication skills, and ability to operate effectively in an international environment and across functions
Strong analytical skills, Quality focus and ability to mentor and coach
Akums Drugs & Pharmaceuticals Ltd., is largest contract manufacturing company engaged in manufacturing of pharmaceutical formulation, ayurvedic/herbal preparations, hormones, nutraceuticals and more.Quality, innovations & customer satisfaction are virtues at Akums. The approach is technologically driven to serve the emerging needs in the ever expanding market. The 9 state of art facilities are dedicated to separate dosage forms across therapeutic segments. The infrastructure is equipped with sophisticated and ultra modern equipments & machines, with huge manufacturing capacities in all sections.In our continuous pursuit of Healthier today and tomorrow, we are working towards redesigning global healthcare.Akums Corporate Movie : https://www.youtube. com/watch?v=-fXYxLwuksY