Associate Manager, Pharmacovigilance| Post-Marketing Case Processing| Hybrid, Bangalore

MMS; Bengaluru Urban; Presencial; INR 1 800 000 - 3 000 000; Tempo integral

Resumo da oferta

MMS is a data-focused CRO committed to impactful pharmacovigilance and regulatory excellence. We seek an experienced professional to lead end-to-end post-marketing case processing, ensuring GVP and FDA alignment, and to mentor teams across global sites.

You will drive process improvements, oversee safety databases, and negotiate with clients while maintaining high-quality deliverables and adherence to regulatory standards.

Qualificações

• 7+ years in drug safety or pharmacovigilance.
• Experience with regulatory requirements and GVP.
• Strong knowledge of pharmacovigilance processes.

Responsabilidades

• Lead and oversee global post-marketing case processing activities from intake through reporting and case closure.
• Develop and maintain pharmacovigilance workflows and SOPs.
• Ensure compliance with GVP, FDA requirements, and company SOPs.
• Proficient in ICH E2A, E2B(R3), and E2D guidelines
• Lead client meetings and provide strategic narrative development.

Conhecimentos

Pharmacovigilance

GVP

MedDRA

WHO Drug Dictionary

Client meetings

Project leadership

Formação académica

Bachelor's degree in scientific/medical field

PharmD

Masters in related field

Ferramentas

MS Office

Descrição da oferta de emprego

Are you looking to join a company where your contributions truly matter, and where you’ll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work® Certified organization, recognized for our exceptional culture and industry-leading employee retention. We support the pharmaceutical, biotech, and medical device industries with our proven scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visitwww.mmsholdings.comor follow MMS on LinkedIn.

Please Note: The final title for this position will be determined based on the successful candidate’s experience, background, and qualifications.

Roles and Responsibilities:

• Lead and oversee global post-marketing case processing activities from intake through reporting and case closure.
• Develop and maintain pharmacovigilance workflows, procedures, and work instructions as related to post marketing case processing.
• Ensure compliance with Good Pharmacovigilance Practices (GVP), FDA requirements, and company SOPs.
• Proficient in ICH E2A, E2B(R3), and E2D guidelines
• Proficient in Pharmacovigilance quality systems
• Maintains an extensive understanding of regulations and guidance as they pertain to drug safety and PV, including case processing, narrative and/or safety writing. Understands clinical trial processes.
• Independent Project lead,SME; provides strategic narrative development internally and externally, directly negotiates with client.
• Process cases independently, understands steps involved with case processing. Leads creation/updates of high-quality deliverables.
• Extensive experience working within a safety database and directly interacts with clients.Expert knowledge of coding with MedDRA and WHO drug dictionary.
• Proficient in understanding impact of updates in related deliverables
• Independently managing/leading client meetings and CRMs for effective resolutions; provides mentorship to others.
• Proficient with managing a project from start to finish and compliant with process; provides mentorship to others; identifies efficiencies within department processes.

Requirements:

• College graduate in scientific, medical, clinical discipline or related field, or related experience, masters, PharmD, or PhD preferred.
• Minimum of 7 years’ experience in drug safety, pharmacovigilance, or similar field required.
• Expert knowledge of scientific principles and concepts.
• Expertise in using drug safety databases.
• Own and drive end-to-end process development, implementation and continuous improvement
• Reputation as emerging leader in field with sustained performance and accomplishment.
• Proficiency with MS Office applications.
• Hands-on experience with clinical trial and pharmaceutical development preferred.
• Good communication skills and willingness to work with others to clearly understand needs and solve problems.
• Excellent problem-solving skills.
• Good organizational and communication skills.
• Familiarity with current ISO 9001 and ISO 27001 standards preferred.
• Familiarity with 21 CFR Part 11, FDA, and GCP requirements.