Senior Manager, Drug Safety Clinical and Post-marketing Operations
Description
Position Overview:
The Senior Manager, Drug Safety Clinical and Post-marketing Operations will lead the management of the pharmacovigilance (PV) vendor on a day to say basis, ensuring that pharmacovigilance and risk management activities are managed in compliance with local regulations and company policies/procedures at a local, regional, and global level and in accordance with any agreements with business partners.
This role with report directly to the Senior Manager, Drug Safety Operations & Compliance and the Drug Safety department and provide process-related expertise, support, and direction for pre- and post-marketing safety related activities.
Key Responsibility Areas:
- Pharmacovigilance Leadership: Back-up to the Senior Manager, Drug Safety Operations & Compliance. Lead pharmacovigilance vendor management oversight activities performed by contract research organizations to ensure compliance with regulatory requirements are being met. Oversee and manage pharmacovigilance activities related to Clinical Trials and Post-marketing activities/requirements. Manage pharmacovigilance agreements with the PV vendor and business partners to ensure compliance is being carried out .
Specific Responsibilities:
Responsibilities include, but are not limited to:
- Lead pharmacovigilance vendor management oversight activities including day-to-day oversight, review, and evaluation of the vendor performance and quality.
- Monitor Key Performance Indicators/ compliance metrics from the pharmacovigilance vendor and monitor for trends or possible improvements.
- Final review of PADER narratives and oversight of submission compliance.
- Develop, execute, and manage Business Partner Agreements, Agreements with PV vendors (i.e. Master Service Agreements, Statement of Work, Change Orders), and other agreements necessary to maintain PV compliance with commitments made and regulatory requirements.
- Oversee and monitor reconciliation performed by PV vendor and Business Partners for accuracy and compliance with business agreements.
- Oversee/manage pharmacovigilance activities related to clinical trials & post-marketing commitments.
- Develop, execute, and manage Clinical, Post-marketing, Safety Management, Investigator-Initiated Study Plans in respects to pharmacovigilance activities in coordination with management.
- Ensure clinical trial and post-marketing case reporting processes are efficient and compliant with regulatory reporting requirements & reporting requirements detailed in the applicable plan/ agreement (i.e. safety management plans (SMP) / PV agreements).
- Provides guidance to PV vendor on technical aspects of clinical trials and post-marketing activities/commitments, including configuration of the Global Safety Database and relevant reporting rules, as applicable.
- Ensure all safety reports received from clinical trials are processed in a consistent and compliance manner.
- Manage SAE/SUSAR reporting activities for all investigational drugs, as applicable.
- Contribute to the preparation of relevant safety sections of: Clinical Study Reports, Annual Reports, Investigator Brochures, Protocols, ICFs, Risk Management Plans, and other regulatory filing documents, as needed.
- Provide responses to Regulatory Agencies’ questions and requests concerning safety/pharmacovigilance activities.
- Serve as a Subject Matter Expert in internal and external pharmacovigilance audits performed by business partners and inspections by regulatory authorities to ensure that questions and matters are adequately addressed.
- Assist in auditing CROs, PV vendors, and business partners who manage and handle Pharmacovigilance responsibilities.
- Keep informed of global new safety regulations, guidance, and policy from the relevant regulatory authorities and notify organization of upcoming changes and status.
- Assist in the development or revision of SOPs, working procedures, guidance documents and safety management plans (SMP) governing Pharmacovigilance functions, as applicable.
- Other pharmacovigilance related functions assigned.
Key Competencies/Requirements:
- Accountability: Assumes responsibility for successfully accomplishing work objectives and delivering business results; setting high standards of performance for self and others.
- Agility: Responds positively to change, embracing and using new practices or values to accomplish goals and solve problems.
- Creativity: Explores and advances opportunities to develop novel solutions and approaches to the improvement of processes and services.
- Empowerment: Finds opportunities to improve and extend contributions to the organization and teammates.
- Integrity: Demonstrates the highest commitment to integrity and shows respect for and values all individuals for their diverse backgrounds, experiences, styles, approaches, and ideas.
- Passion: Shows passion for the organization, our people, and the difference we make daily in improving the lives and health of people.
- Attention to Detail: Ensures that information is complete and accurate; follows up with others to ensure that agreements and commitments have been fulfilled.
- Communication: Delivers clear, effective communication and takes responsibility for understanding others.
- Interpersonal: Develops and maintains effective relationships with others; relates well to people from varied backgrounds and in different situations; shows understanding, courtesy, tact, empathy, concern, and politeness.
Preferred Qualifications:
- A minimum of a bachelor’s degree in a health/biomedical or related field, OR Registered Nurse, Licensed Practical Nurse, or Pharmacist with current certification/licensure (e.g., LPN, RN, RPh, PharmD) required.
- Must have excellent working knowledge of FDA, EU, ICH, and other global regulatory requirements.
- Knowledge of post-authorization commitment requirements is preferred (Phase IV, PASS Studies) and Managed Access Programs (PSPs/etc.) is desirable.
- Ability to work in a fast-paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands.
- Experienced in pre- and post-approval pharmacovigilance activities, including safety reporting.
- Knowledge of clinical trials, and ICH guidelines
- Must have experience in management of safety data exchange agreements.
- Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment.
- Detail-oriented, with good organizational, prioritization, and time management proficiencies.
- Minimum of 5-7 years of experience in a drug safety/pharmacovigilance setting.
- Minimum 3 years benefit/risk assessment experience.
- Case processing and Periodic Adverse Drug Experience Report (PADER) preparation experience.
- Current knowledge of and experience with MedDRA.
- Regulatory experience preferred.
Physical Requirements:
- Frequent talking, hearing, visual acuity (detail/accuracy), and repetitive motion
- Up to 10% travel may be required.
General Statement
Mayne Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Any communication you receive from Mayne Pharma will never come from a personal email domain or chat service such as "gmail" or "Google Chat". All official communication from Mayne Pharma will be received from our company email domain - @maynepharma.com.