Merck Limited (formerly E. Merck Limited) was set up in India as the first Merck subsidiary in Asia in 1967. The Company operates both its Pharmaceuticals and Chemicals businesses in the country. Merck was also the first Merck Group Company to go public in the year 1981. The Merck Group now holds 51% of the share capital in Merck Limited, while the remaining 49% is traded on the Bombay Stock Exchange Ltd. and National Stock Exchange of India Ltd. Merck Specialities Pvt. Ltd.
Post : Associate Manager, Drug Safety
The Pharmacovigilance (PV) Specialist is responsible for the day-to-day case management activities within the country(ies) covered by the country operation including compliance with PV processes and regulations and our policies and procedures. He/she is able to function independently in the processing of adverse events.This includes the procedural responsibilities in the areas of:Adverse experience case management including HA submissions; aggregate safety report health authority submissions and healthauthority submission compliance for individual case safety reports and aggregate safety reports. As requested by the PV CountryLead, the PV Specialist may undertake other additional activities including projects.
Key Responsibilities :
• (PV Country Lead will amend/delete the lists below according to the actual activities assigned. It is not an expectation or requirement that the PV Specialist undertakes all the activities / responsibilities listed.)
• Responsible for day-to-day adverse experience case management within the country(ies) covered by the country operation including case intake and follow-up activities in accordance with Global Safety procedures, the review of local literature as per Compay procedure and country regulations, and health authority submissions of cases in accordance with Global Safety procedures and health authority requirements.
• Responsible for aggregate safety report submissions in the country(ies) in accordance with Global Safety procedures and health authority requirements.
• Responsible for the reconciliation of adverse events reports received from other company operating units (e.g., Designated Point of Contact, Medical Information, etc.) and contractual partners, as applicable
• Responsible for the filing, storage and archiving of safety-related data in accordance with our policies and local requirements.
• Serve as the local Deputy Qualified Person for PV (QPPV) / deputy local responsible PV person for the country(ies) when delegated by PV Country Lead.
• Serve as back-up in the absence of the PV Country Lead to ensure business continuity.
• Responsible for being compliant with local PV regulations, our policies and procedures and Global Safety procedures at the country level.
• Participate in individual case safety report compliance activities and takes the necessary corrective actions locally for the late reporting within the country(ies) covered by the country operation.
• Assist in preparation for audits/inspections for their country/territories and may participate in the audit and/or inspection.
• Identify and communicate potential safety issues to PV Country Lead.
• Assist in the delivery of training to PV staff and customer facing non-PV staff (e.g., Sales Reps, Medical Information, etc.) and distributors / vendors / business partners in the country(ies) within scope.
• Complete and document required PV training within the required timelines.
• Perform other activities as requested by the PV Country Lead.
The incumbent must have a health, life science, or medical science degree or equivalent by education / experience. He/she should have at a minimum 1 year of pharmaceutical industry experience. He/she must have an awareness of Pharmacovigilance regulations within his/her assigned country(ies). The PV Specialist is expected to have strong communication and time management skills, and have the ability to work independently with minimal supervision.
- awareness of pharmacovigilance systems & requirements
- awareness of pharmacovigilance principles, concepts, practices & standards
- knowledge of the local country(ies) pharmacovigilance regulations & obligations
- awareness of Good Clinical Practice concepts
- excellent written & spoken English
- ability to communicate effectively verbally and in writing
- proficient in local language(s)
- proficient in Good Documentation Practices
- good word processing, presentation & spreadsheet application skills
- familiar with the use of a safety database
- ability to learn new computer interface systems
- Strong project management skills with the ability to prioritise assignments
- Excellent time management, organizational & planning skills
- High level of accuracy & quality in work
- Strong collaboration skills with the ability to work across boundaries
- Sense of urgency and the ability to make rapid, disciplined decisions
- Compliance mindset/focused
- Courage and candor