Senior Pharmacovigilance Specialist - Pharmaceutical

Placements24; Durban; Hybrid; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Medical benefits

Retirement plan

Hybrid work model

Professional development

Job summary

Placements24 is seeking a Senior Pharmacovigilance Specialist for a Durban-based hybrid role. You will lead safety surveillance for assigned products, assess adverse events, and ensure timely regulatory reporting to global authorities while collaborating with Medical Affairs and Regulatory teams.

The ideal candidate has a Bachelor's in Pharmacy or Life Sciences, at least 4 years in pharmacovigilance, and strong knowledge of FDA/EMA/CIOMS guidelines, with experience in PV databases and safety

Qualifications

• Bachelor's degree in Pharmacy, Medicine, Life Sciences or related field.
• Minimum 4 years of pharmacovigilance or drug safety experience.
• Thorough knowledge of global pharmacovigilance regulations (FDA, EMA, CIOMS).
• Experience with adverse event reporting systems and pharmacovigilance databases.
• Strong analytical and critical thinking skills with excellent attention to detail.
• Ability to work independently and in a team.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office Suite.

Responsibilities

• Process, evaluate, and report adverse event data per global regulatory requirements and SOPs.
• Perform case assessment, determine seriousness and causality, and ensure timely reporting to health authorities and business partners.
• Identify potential safety signals through ongoing monitoring of aggregate safety data.
• Contribute to the preparation and review of PSURs/PBRERs and risk management plans (RMPs).
• Act as a subject matter expert on pharmacovigilance for internal and external stakeholders.
• Participate in regulatory inspections and internal audits related to pharmacovigilance activities.
• Collaborate with Medical Affairs, Clinical Development, and Regulatory Affairs teams on safety-related issues.
• Maintain and update pharmacovigilance databases accurately.
• Contribute to the development and implementation of pharmacovigilance policies and procedures.
• Conduct signal detection activities and contribute to signal validation assessments.

Job description

About the Role

Our client, a prominent player in the pharmaceutical industry, is looking for a dedicated Senior Pharmacovigilance Specialist to join their esteemed team. This position offers a hybrid work arrangement, allowing for a blend of remote flexibility and in-office collaboration in Durban, KwaZulu-Natal, ZA . You will be responsible for the ongoing safety surveillance of assigned pharmaceutical products, ensuring compliance with global regulatory requirements. This role involves the meticulous assessment of adverse event reports, identification of safety signals, and contribution to the preparation of safety documentation for regulatory submissions. The ideal candidate will possess a strong understanding of pharmacovigilance principles and a keen eye for detail. This is a crucial role in safeguarding public health by ensuring the safe use of medicines. You will work closely with various internal departments and external stakeholders to maintain a comprehensive safety profile for our client's products.

Key Responsibilities

• Process, evaluate, and report adverse event data in compliance with global regulatory requirements and company SOPs.
• Perform case assessment, determine seriousness and causality, and ensure timely reporting to health authorities and business partners.
• Identify potential safety signals through ongoing monitoring of aggregate safety data.
• Contribute to the preparation and review of periodic safety update reports (PSURs/PBRERs) and risk management plans (RMPs).
• Act as a subject matter expert on pharmacovigilance matters for internal and external stakeholders.
• Participate in regulatory inspections and internal audits related to pharmacovigilance activities.
• Collaborate with Medical Affairs, Clinical Development, and Regulatory Affairs teams on safety-related issues.
• Maintain and update pharmacovigilance databases accurately.
• Contribute to the development and implementation of pharmacovigilance policies and procedures.
• Conduct signal detection activities and contribute to signal validation assessments.

Requirements

• Bachelor's degree in Pharmacy, Medicine, Life Sciences, or a related healthcare field.
• Minimum of 4 years of experience in pharmacovigilance or drug safety within the pharmaceutical industry.
• Thorough knowledge of global pharmacovigilance regulations (e.g., FDA, EMA, CIOMS).
• Experience with adverse event reporting systems and pharmacovigilance databases.
• Strong analytical and critical thinking skills with excellent attention to detail.
• Ability to work effectively both independently and as part of a collaborative team.
• Excellent written and verbal communication skills.
• Proficiency in Microsoft Office Suite.
• Must be able to work a hybrid schedule based in Durban, KwaZulu-Natal, ZA .

Benefits

• Annual salary of R .
• Comprehensive medical and retirement benefits.
• Generous annual leave entitlement.
• Opportunities for professional development and training.
• Hybrid work model promoting work-life balance.
• Exposure to a wide range of pharmaceutical products.
• Supportive team environment.