MSD Life Science Drug Safety Manager Job Opening – Apply Online
MSD Life Science Drug Safety Manager Job Opening – Apply Online. Life Sciences candidates apply for an Associate Manager, Drug Safety position that is available at MSD. Check out all of the details on the same below:
Name of the Position: Associate Manager, Drug Safety
Location: Vatika Towers, Gurgaon, India
Requisition ID: R57908
Our Human Health Division maintains a “patient first, profits later” ideology. The organization is included sales, marketing, market access, digital analytics and commercial professionals that are passionate concerning their role in bringing our medicines to our customers worldwide.
The Pharmacovigilance (PV) Specialist is in charge of the everyday case management activities within the country(ies) covered by the country operation including compliance with PV processes and regulations and our policies and also procedures. He/she is able to function independently in the processing of adverse events. This consists of the procedural responsibilities in the areas of Adverse experience case management including HA submissions; aggregate safety report health authority submissions and health authority submission compliance for individual case safety reports and also aggregate safety reports. As asked by the PV CountryLead, the PV Specialist might undertake various other additional activities including projects.
Primary responsibilities include, however, are not limited to:
- (PV Country Lead will certainly 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 consisting of case intake and also follow-up activities in accordance with Global Safety procedures, the review of local literary works as per Compay procedure as well as country regulations, and also health authority submissions of cases in accordance with Global Safety procedures and also health authority requirements.
- Responsible for aggregate safety report submissions in the country( ies) based on Global Safety procedures and also health authority requirements.
- Responsible for the reconciliation of adverse events reports obtained from other company operating units (e.g., Designated Point of Contact, Medical Info, etc.) and also contractual partners, as applicable.
- Responsible for the declaring, storage space 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 as well as procedures and Global Safety procedures at the country level.
- Participate in individual case safety report compliance activities as well as takes the necessary corrective activities locally for the late reporting within the country( ies) covered by the country operation.
- Assist in preparation for audits/inspections for their country/territories as well as may participate in the audit and/or inspection.
- Identify as well as communicate potential safety problems to PV Country Lead.
- Help in the delivery of training to PV staff and also customer facing non-PV staff (e.g.,
- Sales Reps, Medical Information, etc.) and also distributors/ vendors/ business partners in the country( ies) within scope.
- Total and also document required PV training within the required timelines.
- Perform other activities as requested by the PV Country Lead.
The incumbent has to have a health, life science, or medical science degree or equivalent by education/ experience. He/she ought to 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, as well as have the ability to work independently with very little guidance.
- awareness of pharmacovigilance systems & requirements.
- awareness of pharmacovigilance principles, concepts, practices & standards.
- knowledge of the local country(ies) pharmacovigilance regulations & obligations.
- awareness of Great Clinical Practice concepts.
- outstanding written & talked English.
- capability to communicate effectively verbally and in writing.
- proficient in the local language( s).
- competent in Good Documentation Practices.
- good word processing, presentation & spreadsheet application abilities.
- familiar with using a safety database.
- ability to learn brand-new computer interface systems.
- Strong project management abilities with the ability to prioritise assignments.
- Exceptional time management, organizational & planning abilities.
- High level of precision & quality in work.
- Strong collaboration skills with the ability to work across boundaries.
- Sense of urgency and also the capability to make rapid, disciplined decisions.
- Compliance mindset/focused.
- Courage and candour.
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