Pharmacovigilance Manager at Drugstoc eHub Limited

About the job

• We are seeking a detail-oriented Pharmacovigilance Manager to join our teamIn this role, you will play a critical role in ensuring the safety and efficacy of our pharmaceutical products by monitoring and evaluating adverse drug reactions and implementing risk management strategies

Job Responsibilities

• Oversee the collection, assessment, documentation, and timely submission of adverse drug reactions (ADRs) and other safety reports to regulatory authorities.
• Ensure case processing is performed in accordance with local and global regulatory requirements.
• Ensure all pharmacovigilance activities are compliant with local and international regulations and guidelines.
• Prepare and submit Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), and other relevant documentation.
• Maintain the pharmacovigilance database and ensure data integrity.
• Participate in audits and inspections; ensure readiness for regulatory inspections.
• Develop and update SOPs for pharmacovigilance activities.
• Conduct ongoing safety surveillance and signal detection.
• Collaborate with regulatory, medical, commercial, and quality teams.
• Provide PV training to internal staff and business partners.
• Support product launches, labeling updates, and communication with healthcare professionals.
• Manage relationships with third-party vendors and affiliates for pharmacovigilance services.

Qualifications and Requirements:

• Bachelor's degree in Pharmacy, Medicine, Life Sciences, or a related field (PharmD, MBBS, BSc, MSc).
• At least 3–5 years of experience in pharmacovigilance, drug safety, or regulatory affairs.
• Strong knowledge of local (e.g., NAFDAC) and international pharmacovigilance regulations.
• Proficiency with PV databases and safety systems 
• Excellent attention to detail, organizational, and analytical skills.
• Strong communication and leadership abilities.

Bonus Points:

• Experience working with multinational pharmaceutical companies.
• Familiarity with Good Pharmacovigilance Practice (GVP) guidelines.
• Certification in Pharmacovigilance or Drug Safety is a plus.