Pharmacovigilance Associate

15 hours ago

Mumbai, India Endeavor Consulting Group Full time

Come join a world renowned, global pharmaceutical corporation If you are an experienced **Pharmacovigilance Associate** with excellent communication skills and the following skills, we would love to speak with you The **Pharmacovigilance Associate** will help support the establishment of the future Local Safety Organization by reviewing current processes/ regulations and develop strategies to implement required distribution rule changes to establish a compliant and effective PV system for a new consumer organization. This position primarily supports the reporting requirements to Global as well as Local Health authorities along with establishment of the future Local Safety Organization. The Pharmacovigilance Associate will review current processes and develop strategies to implement required changes to distribution rules to establish a compliant and effective PV system for the new Consumer organization. Also providing functional oversight of case management activities performed at contracted vendor organizations. Collaborating with staff across various functions within the Consumer Health business as well as across other sectors to facilitate compliant, timely, and efficient execution of regulatory reporting requirements. **Key Responsibilities**: - Responsible for functional oversight and execution/ validation of reporting rules on local as well as global level for consumer portfolio of products - Liaising with Local Safety Office to understand and identify requirements for local reporting requirements for various regions - Identifies and implements process efficiencies and continuous quality improvements to support business objective of cost-efficient sustainable and scalable end to end case management solutions - Develop standard operating procedures, work instructions and training to support reporting activities and ensuring vendor is adequately trained on requirements - Supports the Director in internal audits and external inspections and develops corrective and preventative actions to address non-conformances - Participates in cross-functional governance teams to ensure alignment of priorities among key business partners - Performs other related duties as the need arises **Requirements**: - Demonstrate good knowledge of regulatory reporting requirements globally - Demonstrated experience working in a matrix environment and cross-functional teams - Practical knowledge of global regulatory pharmacovigilance requirements - Understanding of medical terminology and ability to summarize medical information - Ability to view the "big picture" and understand impact of decision taken within the team or function - **Education**: - A minimum of bachelor’s degree in life sciences or health-care field with 5-8 years’ experience in Pharmacovigilance OR - Advanced degree (e.g., MS, MPH, PharmD, or PhD) with 5 years of experience in Pharmacovigilance or related activities industry activities preferred OR - Advanced degree with completion of a 2-year Pharmacovigilance fellowship. **Preferred**: - Working knowledge of safety databases to identify system enhancements and efficiencies including MedDRA and product dictionaries and version updates - Experience working on CAPAs is strongly preferred - Experience authoring and editing controlled documents (e.g., SOPs) is strongly preferred - Experience overseeing vendors and local safety units is strongly preferred

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