Senior Drug Safety Manager, Pharmacovigilance
South San Francisco, CA /
Pharmacovigilance & Safety /
Full-time
/ On-site
At Alector, our mission is to develop therapies that empower the immune system to combat neurodegeneration and cancer. Our team is solely focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, leading healthcare investors, and pharma company partners who share in our commitment to bettering the lives of patients.
As Drug Safety Manager for the Pharmacovigilance team, you’ll work closely with the Associate Director, Pharmacovigilance Operations to ensure study support across programs as well as manage the quality management system. You will be able to contribute across a variety of programs and have broad involvement in work central to Alector’s strategic goals. You will apply your existing technical skills, learn new skills, and play a key role in Pharmacovigilance and help grow the company and guide its direction!
During your first year, your responsibilities and goals will include:
- Routinely solves complex project management issues while overseeing the daily operations of global safety department.
- Demonstrates broad expertise in clinical/medical knowledge, global safety reporting regulations, technical systems, and the competitive environment.
- Independently spearheads the development of department systems including SOPs and department guidelines.
- Able to work independently and bring issues to management's attention as applicable.
- Recognized as an expert/leader and assists others with problem-solving and decision-making.
- Functions as a mentor and resource for less experienced staff.
- Demonstrates initiative in all aspects of work.
- Responsible for metrics, particularly related to safety reporting, and reports to senior management.
- Ensure timely and appropriate Pharmacovigilance support for regulatory inspections.
- Acts as Pharmacovigilance lead in clinical team meetings.
- With guidance from the Associate Director, participate in the training of drug safety staff and other internal and external audiences such as investigator meetings on drug safety-related topics.
- Help develop and implement overall strategies, performance metrics, and reports for process improvements.
Requirements:
- Health care professional degree (PharmD, RN, MD) with at least 2 years of drug safety experience and additional clinical or pharmaceutical experience, or a BS or MS degree with at least 7 years in the area of drug safety or 4 years in drug safety with additional applicable experience.
- Broad knowledge of domestic and international drug safety regulations, industry practices and standards, and clinical knowledge in appropriate therapeutic areas.
- Must have excellent written and oral communication skills, resourcefulness, and personal organization skills.
- Knowledge of MedDRA and WHO DRUG coding dictionaries.
- Solid understanding of Microsoft Word, PowerPoint, Excel, and experience with using Safety Databases.
We'd love to hear from you if:
- You take pride in being persistent, self-motivated, and efficient.
- You thrive in an environment where we work independently and on teams.
- You demonstrate a track record of being a fast learner and troubleshooting independently.
- You have a point of view but are low ego.
Salary Range:
$166,000 - $180,000 a year
Base salary ranges will be determined by the candidate’s level, qualifications, skill set, and experience.
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Alector is a phenomenal place to learn and grow. Alector is a dynamic environment where teams are encouraged to experiment, take ownership of decisions, and question convention to solve complex problems. At Alector, we value shared wins, perseverance, and a growth mindset.
Alector was named on Fortune’s "Best Workplaces in Biopharma" top list for small and medium-sized companies for the second year! And we moved up from #16 to #11 in 2022.
Among the things you'll discover at Alector on Day 1 and throughout your tenure: Committed and driven colleagues, a bold and important company goal, brand-new brightly lit offices in Oyster Point, right at the heart of Biotech Bay. Alector offers flexible remote work options, and competitive compensation and benefits. Come join us!
At Alector, we believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each other’s assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.
