Med CommunicationsCape Town, Western Cape, South Africa · Remote Solely
Pharmacovigilance Aggregate Reporting Lead Position Summary The Pharmacovigilance Aggregate Reporting Lead is a senior expert responsible for leading, coordinating, and overseeing the preparation and submission of aggreg…
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Med Communications
Cape Town, Western Cape, South Africa • Remote Solely
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The Pharmacovigilance Aggregate Reporting Lead oversees the preparation, writing, and submission of periodic safety reports such as PSURs, DSURs, and PADERs. They collaborate with cross-functional teams to ensure regulatory compliance, data accuracy, and timely delivery of safety documentation.
Candidates must hold an advanced degree in life sciences, pharmacy, or medicine, with a preference for postgraduate qualifications in regulatory affairs or drug safety. A minimum of 4 years of pharmacovigilance experience is required, including at least 2 years specifically focused on aggregate report writing.
The Pharmacovigilance Aggregate Reporting Lead is a senior expert responsible for leading, coordinating, and overseeing the preparation and submission of aggregate safety reports across assigned client portfolios. The role encompasses the full lifecycle of periodic and aggregate reporting — including PSURs/PBRERs, DSURs, PADERs, ADCOs, and Line Listings, in compliance with EMA GVP Module VII, ICH E2C(R2), ICH E2F, and FDA requirements. The role acts as the subject matter expert for aggregate reporting and collaborates with signal management, case processing, medical review, and client teams to deliver submission-ready documents within regulatory deadlines.
Education:
Advanced degree in life sciences - pharmacy (PharmD), or Medicine(MD) preferred.
A postgraduate qualification in regulatory affairs, Pharmacoepidemiology, or drug safety is an advantage.
Experience: Minimum 4 years of PV experience, with at least 2 years focused on aggregate/periodic safety report writing at a PV vendor, CRO, or pharmaceutical company. End-to-end PSUR/PBRER experience required; DSURs, PADERs, and RMPs strongly preferred.
Computer Skills: Safety databases (like Oracle Argus Safety, ArisG LifeSphere, Veeva Safety, AB Cube SafetyEasy), document management systems, Microsoft Office Suite (Word, Excel, Outlook, PowerPoint), literature databases (Embase, PubMed). Familiarity with electronic submission tools and aggregate reporting softwares is an advantage.
Remote
The company has reviewed this job description to ensure that essential functions and basic duties have been included. It is intended to provide guidelines for job expectations and the employee's ability to perform the position described. It is not intended to be construed as an exhaustive list of all functions, responsibilities, skills, and abilities. Additional functions and requirements may be assigned by supervisors as deemed appropriate. This document does not represent a contract of employment, and the company reserves the right to change this job description and/or assign tasks for the employee to perform, as the company may deem appropriate.
Disclaimer
By attaching your Curriculum Vitae (CV), resume, and/or completing an online application, you are consenting to the collection, processing, use, transfer (including but not limited to other countries/jurisdictions), storage, and disclosure of your personal data as described in the Med Communications, Inc. Privacy Policy. Please read this policy carefully for more information on your rights regarding personal data protection.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, disability, genetic information, or veteran status.
Recruitment Agency Notice:
Thank you for your interest in working with Med Communications. We kindly ask that recruitment agencies avoid sending unsolicited CVs, as our in-house team manages all hiring processes.
Please be aware that any unsolicited CVs or candidate profiles received without prior engagement or agreement with our recruitment team will be considered free and carry no obligation on the part of Med Communications. We thank you for your compliance with our policy.
Should collaboration opportunities arise, we will reach out to preferred partners proactively. Your understanding and cooperation are appreciated.
Global Medical Affairs service provider: MI contact centers, scientific writing, pharmacovigilance, regulatory writing.
Med Communications is a trusted global provider of medical affairs services to the life sciences industry specializing in medical information contact centers, scientific communications and medical/promotional review, pharmacovigilance, and regulatory writing for over 25 years. Our clinically trained staff has expertise in the following therapeutic areas: -Allergy/ENT -Cardiology -Endocrinology -Gastroenterology -Hematology/Oncology -Infectious Disease -Nephrology -Neurology/CNS -Pulmonology -Women's Health Further specialized pharmacologic specialties and treatment areas include: -Biologics -Gene Editing -Medical Devices -Orphan Drugs & Rare Diseases -Vaccines Each member of our professional staff has industry, clinical, or academic training, and nearly a third of our pharmacists have experience in all three areas of expertise. Working with a team of highly skilled professionals is critical at every stage of the drug development process.
Offices: 5100 Poplar Ave, Suite 450, Memphis, Tennessee 38137, US · Avenida da República 59 7º Piso, Lisboa, Sucursal em Portugal 1050-189, PT · 9 Ploiesti Street, 400157, Central Business Plaza Tower 3, 4th floor Cluj-Napoca, Cluj-Napoca Cluj Romania, Romania, RO
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