STADA is an international pharmaceutical company with a mission to "Care for People's Health as a Trusted Partner" for more than 125 years. The company's business pillars are Consumer Healthcare (CHC) products, generics, and specialty medicines, including biosimilars. STADA products are available in more than 120 countries. In 2022, the region formed by the CIS countries became an independent business unit and was renamed Eurasia with direct reporting to German headquarters. In the region, STADA has fully-fledged companies in most local markets, including Kazakhstan, where STADA Eurasia HQ is located.

Do you want to become part of a dynamic, international team and grow with us? Then apply now as:   

Senior Pharmacovigilance Manager   

Almaty | Kazakhstan (KZ) | Full-time | Permanent | Quality | Professionals 

Job Overview:

The Senior Pharmacovigilance Manager is responsible for overseeing all pharmacovigilance activities within the organization. This role ensures compliance with regulatory requirements, monitors the safety of our products, and leads a team dedicated to identifying, assessing, and mitigating risks associated with drug use.

Key Responsibilities:

• Establish and maintain a local pharmacovigilance system to the extent necessary to comply with regulatory legislation in 11 countries and in accordance with pharmacovigilance agreements with third-party business partners.
• Act as the liaison with STADA AG on pharmacovigilance matters as the authorized person for pharmacovigilance in the relevant territories.
• Understand and comply with company’s SOPs related to pharmacovigilance
• Receive, process, and submit safety reports on medicinal products to regulatory authorities, including within clinical trial frameworks.
• Forward information about adverse reactions to STADA AG within established timelines.
• Submit periodic safety reports (PSUR/PBRER, ARBE) for registered medicinal products and safety reports for drugs in development (DSUR) to regulatory authorities.
• Develop and implement risk management plans for medicinal products
• Regularly monitor local scientific literature and the official websites of regulatory authorities to identify safety information related to the company's products.
• Develop and maintain current local pharmacovigilance documentation, including standard operating procedures and the local pharmacovigilance master file.
• Ensure a documented training process for personnel in drug safety reporting at the local level, and maintain general awareness of the drug safety reporting process.
• Conduct training for external providers with obligations for adverse event reporting.
• Ensure awareness of changes in local legislation that may impact pharmacovigilance activities and areas of responsibility. Assess the impact of changes on local processes and provide information to STADA AG and business partners.
• Ensure proper documentation, archiving, and storage of safety information on the company's products.
• Ensure the continuity of pharmacovigilance activities.
• Serve as the local contact for pharmacovigilance audit and inspection matters.
• Lead and mentor of local PV team
• Work with medical, regulatory, and quality assurance teams to ensure comprehensive safety assessments.

Qualifications:

Bachelor’s degree in Pharmacy, Medicine, or a related field. A Master’s or Doctorate is preferred.

Minimum of 3 years of experience in pharmacovigilance.

Strong knowledge of pharmacovigilance regulations and practices.

Excellent analytical, communication, and leadership skills.

Ability to work effectively in cross-functional teams.

We look forward to receiving your application via our career portal. At jobs.stada.com you will also find numerous other job opportunities, as we are always looking for motivated talents who can strengthen our team with their expertise and personality.