Pharmacovigilance Scientist

Aspen Pharma Group; Gauteng; On-site; ZAR 350,000 - 450,000; Full time

Job summary

Aspen Pharma Group is seeking a professional in pharmacovigilance to support commercial strategies and product safety evaluations in South Africa. The role involves ensuring compliance with regulatory requirements, mentoring team members, and managing safety reporting, thereby contributing to the health of patients through high-quality medicines.

Qualifications

• Experience in pharmacovigilance and regulatory roles.
• Familiarity with safety evaluations and reporting.
• Ability to work with Regulatory Authorities.

Responsibilities

• Mentoring Pharmacovigilance Officers and Medical Writers.
• Preparing safety reports and maintaining guidelines.
• Leading complex pharmacovigilance programs.

Skills

Pharmacovigilance

Regulatory compliance

Project management

Medical writing

Job description

Aspen is a global specialty and branded pharmaceutical company, improving the health of patients worldwide through our high-quality and affordable medicines. Active at every stage of the value chain, we are uniquely diversified by geography, product, and manufacturing capability.

Aspen is a dynamic organization built on entrepreneurial strength and forward-thinking minds. We attract high-performing individuals who are passionate about their careers and have a desire to exceed expectations. At Aspen, not only do we source the best talent, but we also provide a host of opportunities for continuous development.

The Group’s key business segments are Manufacturing and Commercial Pharmaceuticals, comprising Regional Brands and Sterile Focus Brands. We have approximately 9,100 employees at 69 established offices in over 50 countries, and we improve the health of patients in more than 150 countries through our high-quality, affordable medicines.

OBJECTIVE OF ROLE

To support the SA Commercial Business in realizing the commercial strategy and achieving targeted growth and revenue through successful new product introductions and maintenance of the current product portfolio in South Africa and the SADC region. This involves ensuring successful Marketing Authorization and variation approval from SAHPRA and other Regulatory Authorities within the set timeframe.

The role also involves ensuring compliance with Regulatory and Pharmacovigilance requirements for the new product pipeline and existing portfolio, through activities aligned with the South African and SADC Regulatory plans.

Additionally, the role supports the Pharmacovigilance Lead in safety evaluations of all Aspen products across Pharmacare and other entities owned by Aspen, managing review and analysis of safety data concerning the Aspen Group product portfolio.

KEY RESPONSIBILITIES

Key Accountabilities

• Delegated tasks from RA Manager or PV Lead, including representation at meetings when required.
• Mentoring Pharmacovigilance Officers and Medical Writers.
• Reviewing and advising on local and global guidelines, policies, procedures, and SOPs.
• Maintaining awareness of Pharmacovigilance regulatory requirements and developments.
• Managing outsourced data collection and organization with vendors.
• Serving as Subject Matter Expert (SME) in designated areas, overseeing related tasks.
• Preparing safety reports, including aggregate safety reports and PSURs.
• Ensuring Good Documentation Practice.
• Contributing to PV Team quality and compliance targets.
• Leading complex Pharmacovigilance developmental programs.
• Interacting with Regulatory Authorities.

Further responsibilities include project management, medical writing, safety activities like ICSR processing, literature reviews, signal management, training, SOP creation, and adherence to safety procedures.