Associate Director, Drug Safety Operations & Compliance
Description
Position Overview:
The Associate Director, Drug Safety Operations & Compliance encompasses a key leadership role in providing direction/oversight to the Drug Safety department for the design and execution of all pharmacovigilance and risk management processes within Mayne Pharma. He or she is also responsible for the oversight of drug safety compliance, thus always promoting inspection readiness. He or she will serve as the primary drug safety contact for Mayne Pharma. This role with report directly to the Executive Vice President, Global Head of R&D and Chief Medical Officer.
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Key Responsibility Areas:
- Pharmacovigilance Leadership: Oversee the Drug Safety Department personnel on all Pharmacovigilance activities and the contract research organizations to ensure compliance and alignment with regulatory requirements and internal policies/procedures are being met. Address any concerns/issues requiring a higher-level discussion with contracted Pharmacovigilance (PV) vendor.
- Internal Drug Safety Leadership: In addition to overseeing vendor relationships and performance, the Sr Manager is responsible for management of internal Drug Safety staff. This includes day-to-day operational management, goal setting, performance reviews and compensation considerations.
- Risk Evaluation and Mitigation Strategy (REMS) Leadership: Oversee all REMS activities including but not limited to pharmacovigilance, regulatory, and operational decision making on behalf of Mayne Pharma.
Specific Responsibilities:
Responsibilities include, but are not limited to:
- Serve as point of contact for Pharmacovigilance/Medical Information Vendors & Partner companies for all pharmacovigilance related activities.
- Develop/oversee execution of (end-to-end) PV processes and deliverables performed internally, contracted independent consultants, and or vendors to ensure compliance/alignment with regulatory requirements and internal policies/procedures.
- Oversee the development, review, and maintenance of Standard Operating Procedures, working procedures, guidance documents governing Pharmacovigilance functions, as applicable.
- Oversee and monitor Key Process Indicators (KPIs) to assess the effectiveness of pharmacovigilance processes.
- Participates in selection and bidding activities for Pharmacovigilance vendors and contractors.
- Management of any product divestitures (e.g., TSAs) or in-licensing products to insure a coordinated transition.
- Partner with members from the Quality Department to align compliance processes and procedures with existing or required quality processes.
- Contribute to the development and implementation of pharmacovigilance activities within the Quality Management System.
- Collaborate with cross-functional teams to assess and manage risks related to pharmacovigilance activities.
- Lead both departmental and cross-functional meetings and initiatives to increase the awareness, education, training, and leadership for pharmacovigilance compliance.
- Manages the audit process of business partners, CROs, and vendors and adherence to contractual agreements in regard to compliance with pharmacovigilance activities.
- Conduct and lead pharmacovigilance audits on business partners, CROs, and vendors.
- Prepare audit reports, risk assessments, and associated responses.
- Collaborate with internal audit teams and external partners during regulatory inspections and audits
- Track all relevant corrective action / preventative action details from inspections and audits to completion.
- Serve as a primary liaison with Quality Affairs during an FDA Postmarketing Adverse Drug Experience & REMs inspections to ensure that questions and matters are adequately addressed.
- Serve as a Subject Matter Expert in internal and external pharmacovigilance audits performed by business partners to ensure that questions and matters are adequately addressed.
- Keep informed of global new safety regulations, guidance, and policy from the relevant regulatory authorities and notify organization of upcoming changes and status.
- Overall responsibility for setting and managing the Drug Safety budget and allocations across various cost centers & work closely with finance on at least a monthly basis, to track and adjust budget forecasts and spends.
- Inform leadership/senior management of any concerns/issues requiring higher-level notification/input and providing regular updates to internal departmental regarding pharmacovigilance related activities affecting their function.
- 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.
- Ability to work in a fast-paced environment with demonstrated ability to simultaneously manage multiple competing tasks and demands.
- Must have experience in vendor oversight and the management of safety data exchange agreements.
- Experienced in pre- and post-approval pharmacovigilance activities, including safety reporting.
- Minimum of 5-7 years of experience in a drug safety/pharmacovigilance setting.
- Knowledge of and experience in REMS program operations and implementation.
- 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.
Mayne Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. Mayne Pharma also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Mayne Pharma is an E-Verify employer.
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.