Pharmacovigilance Specialist Job - South Africa
MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Responsible for adverse experience case management in his/her country(ies) of responsibility, including case intake and follow-up activities in accordance with Global Safety procedures, the review of local literature as per Merck’s procedure and country regulations, and health authority submissions of cases in accordance with Global Safety procedures and health authority requirements. Associated responsibilities include the preparation of requests for updates/changes to country-level listings for the global safety database and the escalation of global safety database-related problems arising in country(ies). Responsible for aggregate safety report submission management in the country(ies), including report scheduling, submissions and submission compliance entries in accordance with Global Safety procedures and health authority requirements. Responsible for the reconciliation of adverse events reports received from other Merck 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 Merck’s policies and local requirements. Responsible for writing and maintaining the local country PV SOPs, including alignment with Merck policies and procedures and with Global Safety procedures.
Responsible for being compliant with local PV regulations, Merck policies and procedures and Global Safety procedures at the country level. Accountable for monitoring of individual case safety report compliance and aggregate safety report compliance and responsible for the implementation of corrective actions locally, as necessary, for late reporting. Responsible for the monitoring of new/revised HA regulatory information related to PV and for the timely implementation of the new/updated PV regulations communicating changes to the GS Regional 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 industry experience in pharmacovigilance and must be fluent in English while proficiency in Afrikaans would be an advantage. He/she must also have extensive knowledge of Pharmacovigilance regulations within South Africa and Sub Saharan Africa. The PV Specialist is expected to have strong leadership, communication, and problem-solving skills, along with a demonstrated ability to build and manage close relationships with key Health Authorities in his/her country(ies). Experience interacting with auditors / inspectors and conducting qualification audits is a plus
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
Job: Regulatory Affairs Generic Job Title:Spclst, Regulatory Affairs
Primary Location: EMEA-South Africa-Gauteng-Johannesburg
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings: 1
Company Trade Name:MSD
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